Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation
Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that no illnesses or injuries have been reported. The hazard is a functional failure (failure to defog) rather than a direct health risk, fitting the criteria for a moderate severity score.
Plain-English summary
Medline Industries, Inc. is recalling 14,550 units of anti-fog solution packaged in Tyvek peel pouches. This solution is included in various surgical kits, including those for robotic general surgery, laparoscopic cholecystectomy, and general laparoscopy. The recall is due to a degradation in the chemical properties of the solution, which may cause it to not defog properly.
The affected products were distributed nationwide to 37 states and the District of Columbia, as well as to Canada and Malaysia. The anti-fog solution has a component number of 80532/NONFB100B and an expiration date of 12/2020. Specific material lot numbers and impacted kit lot numbers are listed in the official recall documentation.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. Users should stop using the affected anti-fog solution and contact Medline Industries for further instructions.
The recalled product
- Product
- Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LA
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 14,550
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)
- Fog solution Component Number: 80532/NONFB100B
- Material Lot Number: 41186649M
- 41186673M
- 41211955M
- 41186657M
- 41236925M
- 41186665M
- DYNJ904625B (19CBA697)
- DYNJ42835A (19CBA118)
- DYNJ39685A (19BBH495)
- DYNJ32935C (19BBE174)
- DYNJ36418F (19ABN461)
- DYNJ50765B (19BBJ183)
- DYNJ47704C (19BBE810)
- DYNJ0862775N (19CBA813)
- DYNJ43628A (19BBG651)
- CDS984674C (19CBA033)
- CDS984659K (19BBT877)
- CDS984656L (19ABO984)
- DYNJ0665310C (19CBG762)
Distribution
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