Medline Recalls Minor Pack Convenience Kits Due to Open Sterile Seals
Medline Industries is recalling 459 units of Minor Pack convenience kits because open sterile seals may compromise sterility and lead to patient infection.
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 (sterile medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling 459 units of Minor Pack convenience kits (DYNJ58421A and DYNJ40734F) due to a potential packaging defect. The affected kits may exhibit open seals in the sterile pouch packaging.
The open seals may compromise the sterility of the product. If the defect is not detected prior to use, it may lead to contamination of the sterile field or patient infection. The recall covers distribution in Arkansas, Florida, North Carolina, Maryland, and Texas.
Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI-DI codes listed in the recall notice. If the product is found, it should be removed from use and returned to Medline Industries, LP.
The recalled product
- Product
- Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 459
Distribution
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