Medline Recalls Sterile PICC Trays Due to Non-Sterile Component
Medline Industries is recalling sterile PICC trays because a non-sterile component was attached to the outside of the packaging, posing a potential infection risk.
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 risk-of-harm product (infection risk) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Medline Industries, Inc. is recalling 144 sterile PICC trays (Item number DYNJ49177C) due to a packaging error. The affected lots are 16HB4700, 16UB5076, and 17MB6837. The product was distributed in California and New Mexico.
The recall was initiated because multiple surgical packs were assembled with a non-sterile CHG disk labeled as "BIOPATCH" attached to the outside of the sterile pack. This error may pose a potential risk of infection. The kits have been in distribution since March 2016.
According to the source, many of these kits have been used with no reported infections or adverse patient events. The BIOPATCH component is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity. The agency classifies this as a Class II recall.
The recalled product
- Product
- PICC Tray, STERILE, 12 packs each per case.
- Manufacturer
- Medline Industries, Inc.
- Hazard
- Affected units
- 144
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 (3)
- Item number: DYNJ49177C. Lots: 16HB4700
- 16UB5076
- 17MB6837
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, 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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