The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1475-2022·Announced 2022-08-03

Medline skin prep kits recalled due to leaking isopropyl alcohol bottles

Medline Industries is recalling 1,880 units of skin prep convenience kits with models DYNDP1127A and DYNDP1131 distributed nationwide due to leaking bottles of isopropyl alcohol.

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 of a risk-of-harm product where injury has not yet been reported. The leaking bottles of isopropyl alcohol present a material risk of chemical exposure and contamination, but no illnesses or injuries have been reported in the source material.

Plain-English summary

Medline Industries is recalling 1,880 units of convenience kits labeled as WET SKIN PREP TRAY and SKIN PREP TRAY W/CHG due to leaking bottles of isopropyl alcohol. The affected kits are model numbers DYNDP1127A and DYNDP1131, and have been distributed nationwide in the United States.

The kits contain bottles of isopropyl alcohol that may leak, potentially causing exposure to the chemical and contamination of the medical supplies. These kits are used in medical settings for skin preparation prior to medical procedures.

Users of these kits should immediately stop using them. Consumers and medical facilities should identify affected products using the lot numbers on the packaging. For model DYNDP1127A, the affected lot numbers are: 22ABG455, 21FBU537, 21IBF632, 21JBY751, 21LBB154. For model DYNDP1131, the affected lot numbers are: 22DBT130, 22DBK391, 22ABC822, 22OBE201, 21IBR746, 21JBL238, 21KBU021. Contact Medline Industries with the lot number for further instructions.

The recalled product

Product
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device — Skin Prep Kit
Hazard
Affected units
1,880

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 (14)

  • Lot Code: a. Model number DYNDP1127A
  • Lot Numbers: 22ABG455
  • 21FBU537
  • 21IBF632
  • 21JBY751
  • 21LBB154
  • b. Model number DYNDP1131
  • Lot Numbers: 22DBT130
  • 22DBK391
  • 22ABC822
  • 22OBE201
  • 21IBR746
  • 21JBL238
  • 21KBU021

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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