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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 9,133
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.
Part of a larger recall action
This product is one of 5 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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