The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1473-2022·Announced 2022-08-03

Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol

Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.

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: This is an FDA Class II recall involving a medical device with potential chemical hazard from leaking bottles of isopropyl alcohol. No illnesses or injuries have been reported, which aligns with rubric criteria for risk-of-harm products where injury has not yet been reported, scoring 3.

Plain-English summary

Medline Industries is recalling LAP CHOLE convenience kits (Model DYNJ907150) due to leaking bottles of isopropyl alcohol contained within the kits. The leaking bottles pose a potential hazard to users through chemical exposure.

The recall affects 54 units with lot codes 21FBJ077, 21GBJ337, and 21GBJ338. The affected kits were distributed nationwide across the United States.

Customers who have received the affected kits should stop using them immediately. For additional information and instructions, contact Medline Industries or consult the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1473-2022.

The recalled product

Product
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device — Surgical Kit
Hazard
Affected units
54

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 (3)

  • Lot Code: 21FBJ077
  • 21GBJ337
  • 21GBJ338

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - SPT 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.

See all 8 products in this recall →

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