CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.
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 classified as High because it is a risk-of-harm medical device where manufacturing defects could result in medication leakage, with no reported injuries or illnesses to date. The product is used for critical medication delivery, making any device malfunction a patient safety concern.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain CADD Medication Cassette Reservoirs (Product Code 21-7301-24) due to a manufacturing defect that occurred during production.
A production equipment malfunction resulted in weakened weld joints between the medication bag and tubing in affected units. These weakened welds could result in medication leakage during use, potentially affecting the delivery of critical medications to patients.
The recall affects approximately 119,535 units distributed worldwide. Affected lot numbers include: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4040247, 3983339, 3983338, 3983340, 4013367, 4013366, 3988532-ENG, 3983337, 4052406, 4042840, 4052407, 4052408, 4042842, 4048891, and 4052409. The product's unique device identifier (UDI) is 10610586027215.
If you are using or have received one of these cassette reservoirs, inspect it for signs of medication leakage. Do not use the device if leakage or damage is suspected. Contact Smiths Medical or your healthcare provider for instructions on obtaining a replacement device or alternative treatment option.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 119,535
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 10610586027215
- Lot Numbers: 4042839
- 4040248
- 4034021
- 4052405
- 4034022
- 4037748
- 4042841
- 4034019
- 4037749
- 4040247
- 3983339
- 3983338
- 3983340
- 4013367
- 4013366
- 3988532-ENG
- 3983337
- 4052406
- 4042840
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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