The Recall Desk
HighFDA (Devices)·Z-1646-2023·Announced 2023-06-07

Medline sterile surgical procedure packs recalled due to water damage

Medline Industries is recalling three sterile surgical procedure packs that were damaged by water, compromising their sterility. The recall affects 342 packs distributed in California.

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: Water-damaged sterile surgical packs represent a risk-of-harm product where injury has not been reported, fitting the Score 3 criterion per the rubric.

Plain-English summary

Medline Industries, LP is recalling three sterile surgical procedure packs that were damaged by water. The recalled products are: (1) Medline Sterile Arthroscopy Pack (REF: DYNJ64242B), (2) Medline Sterile Shoulder Pack (REF: DYNJ64250A), and (3) Medline Sterile Upper Extremity Pack (REF: DYNJ64253B). A total of 342 packs (114 packs per product) were affected by the water damage.

Water damage compromises the sterile barrier of surgical procedure packs. Packs with compromised sterility may allow bacterial contamination if used during surgical procedures.

The damaged packs were distributed to healthcare facilities in California. The recalled products have the following lot numbers and expiration dates: Arthroscopy Pack Lot #22HMD098 (Exp. 2024-04-30), Shoulder Pack Lot #22JMA673 (Exp. 2024-01-31), and Upper Extremity Pack Lot #HMF900 (Exp. 2024-01-31).

The recalled product

Product
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Packs
Hazard
  • water-damage
  • sterility-compromise

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 (8)

  • (1) Arthroscopy Pack - Lot #22HMD098
  • Exp. 2024-04-30
  • UDI/DI (01)10193489956405
  • (2) Shoulder Pack -Lot #22JMA673
  • Exp. 2024-01-31
  • GTIN (01)10193489429817
  • and (3) Upper Extremity Pack - Lot #HMF900
  • UDI/DI (01)10193489968453.

Distribution

Distribution scope not specified by the agency.

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