Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries recalls surgical kits and trays manufactured with non-sterile solutions due to contaminated Nurse Assist components. Kits distributed nationwide and internationally may lack proper sterility, posing infection risk.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per rubric guidelines, FDA Class I cannot score below Severe (4). No illnesses or deaths have been reported, but non-sterile solutions used in surgical eye procedures create significant infection risk.
Plain-English summary
Medline Industries, LP is recalling 5,724 units of surgical kits and trays used in ophthalmic procedures, including cataract packs, eye kits, oculoplasty packs, and vitrectomy packs with specific reference numbers and lot codes.
The kits were manufactured using contaminated components from Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. These components were produced without proper sterility assurance, resulting in solutions that may be non-sterile.
The affected kits were distributed nationwide across the United States, including Puerto Rico, as well as internationally to Canada, the United Arab Emirates, and Panama.
Healthcare facilities and providers who have received these kits should stop using them immediately. Contact Medline Industries, LP for instructions on return or replacement of affected products. If non-sterile irrigation solutions were used during any procedures, patients and healthcare providers should consult appropriate medical guidance regarding potential infection risk.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 5,724
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)
- a) REF VAL011CTASD
- UDI/DI 40195327152032 (case)
- 10195327152031 (unit)
- Lot Numbers: 22LBB812
- 22LBH455
- b) REF DYNJ68875F
- UDI/DI 40195327382125 (case)
- 10195327382124 (unit)
- Lot Numbers: 23FBQ273
- 23GBS122
- 23GBS486
- 23HBP752
- c) REF DYNJ54869F
- UDI/DI 40195327407286 (case)
- 10195327407285 (unit)
- d) REF DYNJ44917L
- UDI/DI 40195327472604 (case)
- 10195327472603 (unit)
- Lot Numbers: 23HBS811
- e) REF CDS983585G
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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