BALLARD Multi-Access Port Catheter Recalled for Incorrect Expiration Date
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
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 Class II recall involves a sterile medical catheter distributed with an incorrect expiration date. No illnesses or injuries have been reported. However, incorrect expiration dating on sterile medical devices creates a risk of non-sterility and potential patient harm, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Avanos Medical, Inc. is recalling 2,520 BALLARD Multi-Access Port (MAP) Catheters (Double Swivel Y-Adult, 16 French) that were distributed with an incorrect expiration date. The affected devices were supplied in 126 cases under lot numbers 30135997, 30137462, 30138710, 30140310, and 30141359.
The catheters were labeled with an expiration date that does not match the actual product expiration. Use of a sterile medical device beyond its expiration date may result in loss of sterility and compromise product safety.
The affected devices were distributed worldwide, including in the United States (Oklahoma and Ohio) and internationally to China, France, Germany, Great Britain, Greece, Italy, and the Netherlands.
Patients and healthcare providers who received these devices should verify the lot number against the recall list and contact Avanos Medical or their healthcare provider if they have concerns about whether their device was affected.
The recalled product
- Product
- BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- expiration-date-error
- sterility-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 (7)
- Finished Product Code: 102007202
- Alternate Code: 240168-5
- Lot No.: 30135997
- 30137462
- 30138710
- 30140310
- and 30141359.
Distribution
Distributed nationwide across the United States.
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