The Recall Desk
HighFDA (Devices)·Z-1163-2023·Announced 2023-03-01

Medline Sterile Hand Pack recalled for inadequate sterilization

Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.

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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—improper component placement preventing sterilization—represents a risk-of-harm scenario in a high-risk clinical setting where injury has not yet been reported, per the rubric.

Plain-English summary

Medline Industries, LP is recalling Medline Sterile Hand Pack surgical preparation kits (Item DYNJ63380A and DYNJ63380C) containing BD Chloraprep Hi-Lite Orange applicators. The recall affects 1,689 trays due to improper placement of some components in the nonsterile portion of the tray, which prevented those components from being sterilized.

These kits are used for antiseptic skin preparation in surgical and clinical settings. Components that did not receive proper sterilization create a potential risk of contamination during use that could compromise the effectiveness of the antiseptic preparation process.

The recalled products were distributed nationwide in Arkansas, Colorado, and Georgia. Specific lot numbers and expiration dates are listed in the FDA recall notice (Z-1163-2023).

Healthcare facilities and clinics that received these products should stop using the affected lot numbers and contact Medline Industries for instructions on how to return or dispose of the recalled items.

The recalled product

Product
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor P
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Preparation Supplies
Hazard
  • inadequate-sterilization
  • contamination-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) UDI/DI (01) 40193489230339
  • Lot numbers 21DLA284
  • exp. 10/31/2023
  • 21BLA250
  • exp. 2/28/2023
  • 20JLA617
  • exp. exp. 2/28./2023
  • 20ILA666
  • 20ILA518
  • 20ILA217
  • and 20ILA054
  • exp. 11/30/2022. (2) UDI/DI (01) 40193489956895
  • Lot numbers 21HLA016
  • exp. 12/31/2023
  • 21ILA354
  • 21JLA196
  • 21KLA245
  • exp. 1/31/2024
  • 21LLA141
  • 22ALA377

Distribution

Distributed nationwide across the United States.

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