Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
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 is a Class II recall of a medication delivery device with a confirmed manufacturing defect that could result in medication leakage. While no injuries or illnesses have been reported, this qualifies as a risk-of-harm product recall where failure could affect patient care.
Plain-English summary
Smiths Medical ASD Inc. is recalling approximately 2,881,080 units of certain CADD Medication Cassette Reservoirs worldwide. The affected device is the ENT RES 100 ML Non-Sterile model with clamp, tubing flag, and female Luer connector (Product Code 68-2230-28, UDI/DI 30610586044179).
During manufacturing, a production equipment malfunction resulted in a weakened weld joint between the medication bag and tubing component. This defect could result in medication leakage during device use.
Healthcare facilities and patients using these devices should verify their lot number against the recall notice. Affected product lot numbers are provided in the FDA recall announcement. If your device is affected, contact Smiths Medical for further instructions.
The recalled product
- Product
- ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- medication-leakage
- manufacturing-defect
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 (20)
- UDI/DI 30610586044179
- Lot Numbers: 4010559AB
- 4010560AB
- 4010563AB
- 4010573AB
- 4016496AB
- 4010561AB
- 4010562AB
- 4016490AB
- 4010570AB
- 4010569AB
- 4016494AB
- 4016497AB
- 4010571AB
- 4016491AB
- 4010572AB
- 4010574AB
- 4016493AB
- 4022630AB
- 4025275AB
Distribution
Distribution scope not specified by the agency.
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