Smiths Medical Y-Piece Airway Connector Recalled Due to Sterile Packaging Integrity Uncertainty
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a sterile medical device with potential for contamination if packaging seal integrity is compromised. No reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Smiths Medical ASD Inc. is recalling the Portex Y-Piece 15MM airway connector (Reference 100/276/000). The recall affects 9,133 units distributed worldwide, including lot numbers 4131841, 4122012, and 4133227.
The recall is due to uncertainty in the seal integrity of the sterile packaging. If the seal is compromised, the sterility of the device could be compromised.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- smiths medical portex, Y' PIECE 15MM, REF 100/276/000
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- seal-integrity
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 35019315011003
- Lot Numbers: 4131841
- UDI/DI 35019315022405
- Lot Numbers: 4122012
- 4133227
Distribution
Distribution scope not specified by the agency.
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