ENT Medication Reservoirs Recalled for Weakened Weld Joint
Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.
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: This FDA Class II recall involves a documented structural defect in a medication delivery device. Although the hazard is real, the source text contains no reports of illnesses, injuries, or hospitalizations. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain ENT RES 100 ML Non-Sterile medication reservoirs with clamp and female Luer connector (product code 68-2231-28). Approximately 120,960 units are subject to this recall.
A production equipment malfunction has resulted in weakened weld joints between the medication bag and tubing in certain units. This structural defect could cause medication leakage during clinical use.
The affected reservoirs have been distributed worldwide. Healthcare facilities and patients currently using any of the affected lot numbers (3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, and 4146021AB) should discontinue use and contact Smiths Medical ASD Inc. for instructions on obtaining replacement units.
The recalled product
- Product
- ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 120,960
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 (9)
- UDI/DI 30610586044186
- Lot Numbers: 3997242-ENG
- 4040002AB
- 4040000AB
- 4040001AB
- 4040008AB
- 4040007AB
- 4040009AB
- 4146021AB
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 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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