Medline Recalls Bard MYPICC Kits Due to Potential Sterilization Failure
Medline Industries is recalling specific Bard MYPICC Kits because one case may not have been sterilized. The product was distributed to UT.
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: The recall involves a potential failure of sterilization for a medical device used in vascular access, which poses a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (4) which requires hospitalization reports or structural defects.
Plain-English summary
Medline Industries, Inc. is recalling specific units of the Bard MYPICC Kit, Reference CK000095B, 5F French Size. The recall involves 6 cases of 5 kits each, identified by Lot 17YM5936 with an expiration date of 04/30/2019. These sterile, prescription-only kits are intended for use in vascular access procedures.
The recall was initiated because one of the cases of product might not have been sterilized. The source text does not specify which specific case within the lot was affected, nor does it report any illnesses or injuries associated with the use of these devices.
The product was distributed to UT. Consumers and healthcare providers who have this specific lot number should stop using the product and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Vascular Access
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 (2)
- Lot 17YM5936
- Exp. 04/30/2019
Distribution
Distributed in 1 state:
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