Medline Sterile Ophthalmic Convenience Kits Recalled for Weak Breather Pouches
Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.
What this means for you
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: This is a Class II medical device recall where open or weak package seals could compromise sterility of surgical instruments used in eye procedures, creating a risk of surgical site infection. The source text contains no reports of actual illness or injury, making this a theoretical risk-of-harm product.
Plain-English summary
Medline Industries, LP is recalling select sterile ophthalmic convenience kits because purchased breather pouches used for packaging may have open or weak seals. The recalled kits are used for various eye procedures including cataract, vitrectomy, and ophthalmic plastic surgery procedures. A total of 3,909 units have been distributed worldwide, including to the US nationwide and Canada, Mexico, Panama, and the US Virgin Islands.
Compromised packaging seals could allow the sterile contents to become non-sterile. Patients receiving surgical procedures with non-sterile instruments may face increased risk of infection.
Healthcare facilities and practitioners who have received affected kits should stop using them and contact Medline Industries for instructions. The affected kits can be identified by specific model numbers and lot numbers listed by the manufacturer.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- package-seal-failure
- sterility-compromise
- infection-risk
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 (20)
- 1) DYNJ41097A
- UDI-DI: 10888277213487(each)
- 40888277213488(case)
- Lot Number: 24IBF244
- 2) DYNJ60631B
- UDI-DI: 10193489994421(each)
- 40193489994422(case)
- Lot Number: 24IBG352
- 3) DYNJ80316A
- UDI-DI: 10195327245221(each)
- 40195327245222(case)
- Lot Number: 24IBG593
- 4) DYNJ63707C
- UDI-DI: 10193489883503(each)
- 40193489883504(case)
- Lot Number: 24IBH027
- 5) DYNJ85284
- UDI-DI: 10195327486457(each)
- 40195327486458(case)
- Lot Number: 24IBH266
Distribution
Distributed nationwide across the United States.
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