Sterile eye procedure kits recalled over pouch packaging with open seals
Medline is recalling 1,024 Sterile Basic Eye Pack 16 kits because the pouch packaging may exhibit open seals.
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: Scored 3 under the risk-of-harm criterion: an open seal on a sterile eye procedure kit creates an infection risk, and no injuries are reported.
Plain-English summary
The MEDLINE Sterile Basic Eye Pack 16, REFs DYNJ37743D and DYNJ37743F, is being recalled.
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
The recall covers 1,024 units. The DYNJ37743D pack carries UDI/DI 10193489600124 for each unit and 40193489600125 for the case, lot 25EMI333. The product was distributed in Missouri. The FDA has classified the action as Class II.
An open seal means the sterile barrier may not have held on a kit used for eye procedures. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Medline's instructions.
The recalled product
- Product
- MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 1,024
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 (6)
- 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each)
- 40193489600125 (case)
- Lot Number 25EMI333
- 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each)
- 40198459390686 (case)
- Lot Number 25GMD927.
Distribution
Distributed in 1 state:
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