On April 1, net of official of bureau of national medicine inspect releases announce to say, control government to enhance quality of medical apparatus and instruments, use safety of product of safeguard medical apparatus and instruments is effective, total bureau of supervisory government of medicines and chemical reagents of former state provision organizes 5 breed such as catheter of pair of medical and surgical guaze mask, one-time use asepsis in all 162 batches product undertook quality supervises sampling observation, among them 12 batches of products do not accord with a standard to set. Particular case announcement is as follows:
Be notted agree with to combine the product of medical apparatus and instruments that the standard provides by sampling observation project, 5 variety that involve 10 companies 12 batches. Specific for:
1
Condom of natural latex balata 3 enterprises 3 batch product. Zhan Jiang city collects the 1 batch that limited company produces the course of study that connect medicine pinhole of condom of natural latex balata does not accord with a standard to set; Karex Industries Sdn.Bhd. (agent: Limited company of science and technology of medicine of Guangzhou city unify) , Thai Nippon Rubber Industry Public Company Limited (agent: Limited company of trade of Guangzhou city beautiful Cheng) each 1 batch of production is natural latex balata condom, blow up without ageing bulk and bursting pressure do not accord with a standard to set.
2
Blood is dialytic reach relevant cure to use condensate an enterprise 2 batch product. The 2 batch that friend of Tianjin city kidney amounts to technology of medical treatment equipment to develop limited company to produce are dialytic powder, solute chroma (potassium ion, chloric ionic chroma) do not accord with a standard to set.
3
Catheter of one-time use asepsis 2 enterprises 3 batch product. Hunan attain the 2 batch that limited company of things of He Yikang medical treatment produces are one-time the 1 batch of use catheterization bag, Shanghai of production of limited company of science and technology of 1000 hill medical treatment is one-time use asepsis catheter, EO incomplete allowance does not accord with a standard to set.
4
Dilator of vagina of one-time use asepsis 2 enterprises 2 batch product. Each 1 batch that limited company of limited company of development of Kang Minwei material of city of new rural area, medical apparatus and instruments of Henan province blue sky produces is one-time dilator of use asepsis vagina, allowance of incomplete of annulus oxygen ethane does not accord with a standard to set.
5
Medical and surgical guaze mask 2 enterprises 2 batch product. The 1 batch that Tianjin city distant ship is versed in trade develops limited company to produce is one-time medical and surgical guaze mask, new the 1 batch that limited company produces country city Hua Xiwei material is medical and surgical guaze mask, pressure is poor (Δ P) do not accord with a standard to set.
2 breed that sampling observation project accords with the product of medical apparatus and instruments that the standard provides to involve 101 companies entirely 150 batches.
Do not accord with a standard to provide a product to what discover in afore-mentioned sampling observation, supervisory management board of national medicines and chemical reagents already asked enterprise seat is provincial supervisory management department of medicines and chemical reagents supervises and urge relevant enterprise according to " medical apparatus and instruments monitors regulation " " recall of medical apparatus and instruments runs way " wait for code the product that regulations asks not to accord with a standard to set to sampling observation undertakes the risk is evaluated, determine recall level according to the serious degree of blemish of medical apparatus and instruments, active recall product publishs recall information. In the meantime, the enterprise should find out a product as soon as possible unqualified reason, make rectify and reform measure and rectify and reform on schedule reach the designated position, about deal with circumstance on April 30, 2019 forward the society is announced, seasonable will relevant circumstance reports to seat provincial medicines and chemical reagents supervises management department.
Supervisory management department of provincial medicines and chemical reagents answers enterprise seat relevant enterprise undertakes investigating handling, undertake to the enterprise product recall, unqualified reason is investigated, fulfil rectify and reform the circumstance such as measure and public exposure information to undertake supervisory; The product causes harm to perhaps evidence proves the likelihood endangers human body health to human body, should accept suspension lawfully production, manage, use urgent control measure; Need suspends an import, answer to sign up for national medicines and chemical reagents in time to supervise management board to make administration handle a decision. The enterprise did not fulfil afore-mentioned requirements by the requirement, supervisory management department of provincial medicines and chemical reagents should investigate seat gravely lawfully. Concerned information should be made public in time to the society.
Above fulfils a circumstance each, relevant and provincial medicines and chemical reagents supervises management department to control management board at medicines and chemical reagents of nation of the report before May 10, 2019.
Sampling observation of national medical apparatus and instruments does not accord with a standard to provide product list
Serial number
Designation produces the name of an article to say
Unit be selectivinged examination
Designation produces a business
Norms model
Manufacturing date / lot number / leave factory number
Sampling unit
Checklist
Do not accord with a standard to set a project
1
Condom of natural latex balata
The the Changsha City always starts limited company of medical apparatus and instruments
Zhan Jiang city collects the estate that connect medicine limited company
2mm of smooth face 52 ±
20170712 7072
Medicines and chemical reagents of Hunan Province food controls management board
Guizhou Province medical apparatus and instruments detects center
Pinhole
2
Condom of natural latex balata
Limited company of science and technology of medicine of Guangzhou city unify
Karex Industries Sdn.Bhd.
52mm ± 2mm is flowing and ultrathin model
02/2018 18N0376
Guangdong saves food medicines and chemical reagents to control management board
Hunan Province medical apparatus and instruments examines detect
Blow up without ageing bulk and bursting pressure
3
Condom of natural latex balata
Limited company of trade of Guangzhou city beautiful Cheng
Thai Nippon Rubber Industry Public Company Limited
Condom of smooth face of 52mm ± 2mm balata (common model)
02/2018 N01180206
Guangdong saves food medicines and chemical reagents to control management board
Hunan Province medical apparatus and instruments examines detect
Blow up without ageing bulk and bursting pressure
4
Dialytic powder
Jilin university the 2nd hospital
Friend of Tianjin city kidney amounts to technology of medical treatment equipment to develop limited company
Model: P4-1
A pink: On April 27, 2018
B pink: On March 30, 2018 A pink: 1804095 B pink: 1803096
Jilin saves food medicines and chemical reagents to control management board
Beijing medical apparatus and instruments examines
Solute chroma (potassium ion, chloric ionic chroma)
5
Dialytic powder
Hospital of continous in relief downtown
Friend of Tianjin city kidney amounts to technology of medical treatment equipment to develop limited company
A: P4-1/2347 overcomes B: P4-1/588 gram
A: 20180320, B: 20180412 A: 1803040 B: 1804032
Sichuan saves food medicines and chemical reagents to control management board
Guangdong saves quality of medical apparatus and instruments to supervise examine
Solute chroma (potassium ion, chloric ionic chroma)
6
One-time use catheterization is wrapped
Hunan attain limited company of things of He Yikang medical treatment
Hunan attain limited company of things of He Yikang medical treatment
16#
20180426
Medicines and chemical reagents of Hunan Province food controls management board
Jiangxi saves medical apparatus and instruments to detect center
EO incomplete allowance
7
One-time use catheterization is wrapped
Hunan attain limited company of things of He Yikang medical treatment
Hunan attain limited company of things of He Yikang medical treatment
16#
20171225
Medicines and chemical reagents of Hunan Province food controls management board
Jiangxi saves medical apparatus and instruments to detect center
EO incomplete allowance
8
Catheter of one-time use asepsis
Limited company of 1000 science and technology of hill medical treatment
Limited company of 1000 science and technology of hill medical treatment
CR-3-Fr24-M is lubricant model 3 antrum Fr24/30mL
2017.12.21 20171221
Shanghai food medicines and chemical reagents controls management board
Shandong visits center of quality inspection of product of medical apparatus and instruments
EO incomplete allowance
9
Dilator of vagina of one-time use asepsis
Kang Minwei material of city of new rural area develops limited company
Kang Minwei material of city of new rural area develops limited company
Middle-sized
On April 26, 2018 20180426
Henan saves food medicines and chemical reagents to control management board
Heibei saves medical apparatus and instruments and medicines and chemical reagents to pack material to examine academy
Remain of annulus oxygen ethane is measured
10
Dilator of vagina of one-time use asepsis
Henan saves limited company of blue sky medical apparatus and instruments
Henan saves limited company of blue sky medical apparatus and instruments
Middle-sized / push-pull type
On April 4, 2018 02018040308
Henan saves food medicines and chemical reagents to control management board
Heibei saves medical apparatus and instruments and medicines and chemical reagents to pack material to examine academy
Remain of annulus oxygen ethane is measured
11
One-time medical and surgical guaze mask
Tianjin city distant ship is versed in trade expands limited company
Tianjin city distant ship is versed in trade expands limited company
YH-I (asepsis) rectangle
20180119 180116
Tianjin city market and quality control administrative committee
Liaoning saves medical apparatus and instruments to examine detect courtyard
Pressure is poor (Δ P)
12
Medical and surgical guaze mask
Hospital of people of river pool city
Hua Xiwei material of city of new rural area limited company
Norms: 9.5cm × 17cm (allow differs ± 1cm)
On December 18, 2016 06161218
Medicines and chemical reagents of food of Guangxi Zhuang Autonomous Region controls management board
Beijing medical apparatus and instruments examines
Pressure is poor (Δ P)
The character edits / Hiroshima
Art edits / Shui Chuan
Origin / network of Chinese quality news
