20 February 2019

Circular # 20-Safety alerts for the medical device Sterile Saline and Sterile Water for Inhalation

Reference: CIR-2019-00000057

With reference to the above subject, Dubai health authority is alerting all health facilities on the recent circular issued by MOHAP regarding the warning alert issued by the US Food and Drug Administration has issued a warning about the withdrawal a range of the above medical device for the manufacturer company Medex Cardio-Pulmonary/Smiths Medical because of the possibility of contamination of bacteria as a result of damage to the containers used for these products during the process of packaging, which may lead to infection in patients who use these products

 

The following are the affected batch’s numbers :

1
Portex 350ml sterile water humidifier w/5psi adapt ( model #352 lot number A214 ,A215 ,Z263 ,Z532 & Z555)
2
Portex 550ml sterile water humidifier w/5psi adapt ( model #552 lot number A054 , A089, A090 & Z262)
3
Portex 1000ml sterile water USP Pour Bottle ( model #1065 lot number B209 & Z225)
4
Portex 500ml sterile water USP Pour Bottle ( model #1565 lot number Y371)
5
Intermed 350ml sterile water humidifier w/5psi adapt ( model #0352IMJ lot number (A457,A597,B157, Z589,Z655,Z65 & Z661
6
Portex 550ml sterile water humidifier w/5psi adapt ( model #552C lot number Z370)
7
Intermed 550ml sterile water humidifier w/5psi adapt ( model #552IMJ lot number (Z588, Z597)
8
Medline 300-350ml sterile water humidifier w/5psi adapt ( model # HCS00300 lot number Y576)
9
Medline Prefilled 350ml sterile water ( model # HCS00350 lot number A055 , A056, A057, A058, A103, A176, A455 ,B530, B531 , B532, B533 ,Z101 , Z534, Z553 & Z554)
10
Portex Unit dose 5ml Normal Saline (0.9%) ( model # R0059 lot number B360 , K820227
11
Portex Unit dose 15ml Normal Saline ( model # R0159 lot number A661, B067, A526, A536, A569 & B201
12
Portex 5ml Normal Saline (0.9%) Unit dose ( model # UD9005 lot number B515 , K820227
13
Medline Prefilled 550ml sterile water ( model # HCS00550 lot number A092 , B205, B534 & Z205
 

Noted that product is not registering in the Drug Control in the MOHAP

 

Important links:

For more information about the warning kindly visit the website

https://www.fda.gov/medicaldevices/safety/listofrecalls/ucm630614.htm

Supporting Documents:

Circular # 20-medical device Sterile Saline and Sterile Water for Inhalation.pdf:

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