Medline Recalls Cataract Convenience Kits Due to Open Sterile Seals
Medline Industries is recalling 336 cataract 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, fitting the High severity criteria for potential patient infection.
Plain-English summary
Medline Industries, LP is recalling 336 units of Convenience Kits CATARACT PACK (DYNJ59881A) due to a potential sterility issue. The recall involves kits that may exhibit open seals in the sterile pouch packaging. The affected products are identified by UDI-DI 10198459020612 and Lot 25GBP246.
The open seals may compromise the sterility of the product. If the issue is not detected prior to use, it may lead to contamination of the sterile field or patient infection if the product is used. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the states of Arkansas, Florida, North Carolina, Maryland, and Texas. Healthcare providers and facilities should check their inventory for the specific lot number and UDI-DI listed above and stop using any affected kits.
The recalled product
- Product
- Convenience kits CATARACT PACK DYNJ59881A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 336
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 (1)
- UDI-DI 10198459020612 Lot 25GBP246
Distribution
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