Recall Z-2466-2023
Smiths Medical ASD Inc. · initiated July 18, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Codes / lots: UDI/DI 30351688410645, Lot Numbers: 3419998, 3420441, 3429265, 3432722, 3440006, 3467682, 3467683, 3475349, 3489248, 3493797, 3509569, 3521742, 3526245, 3526337, 3529553, 3529672, 3533982, 3542040, 3546408, 3564993, 3570687, 3570840, 3576129, 3576138, 3635067, 3646546, 3658725, 3678314, 3688406, 3695958, 3696009, 3708884, 3727517, 3728938, 3745100, 3754085, 3764388, 3768464, 3784917, 3788804, 3791099, 3798345, 3802616, 3806235, 3843436, 3846795, 3855864, 3855865, 3858487, 3862085, 3864846, 3867640, 3867641, 3874801, 3878332, 3881026, 3884523, 3891892, 3904937, 3917655
Reason for recall
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
FDA-determined cause: Device Design
Action taken
Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 07/18/2023 by U.S. Mail. The notice explained the problem, potential risk, and requested the consignees perform the following actions: 1. Discontinue use and distribution of affected product; quarantine all product 2. Inform all users within your facility 3. If the product was further distributed, please indicate the contact information for the new owner of the product on the response form. Smiths Medical is seeking the return of the affected product.
Details
- Recall number
- Z-2466-2023
- Initiated
- July 18, 2023
- Posted by FDA
- August 28, 2023
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Quantity
- 66,633 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Smiths Medical ASD Inc., Minneapolis, MN