The Recall Desk
HighFDA (Devices)·Z-1081-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging

Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.

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 involving risk-of-harm products where blade puncture could compromise packaging sterility. No illnesses or injuries are reported in the source; the hazard is theoretical. Meets rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP has issued a recall of Sterile Procedural Trays labeled as Wound Closure Tray (Item Number DYNJ56703) and Wound Pack (Item Number DYNJ80201A). The recall affects 36 cases containing a total of 116 units, distributed worldwide to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

The recall concerns Lot Number 22JBE355 (Wound Closure Tray) and Lot Number 22IBE619 (Wound Pack). Sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging. This packaging breach could compromise the sterile integrity of the medical device kits.

Healthcare facilities that have received these products should verify their inventory using the provided lot numbers and item numbers.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Procedural Kits
Hazard
  • blade-puncture
  • 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 (10)

  • a. WOUND CLOSURE TRAY
  • Item Number: DYNJ56703
  • Case UDI/GTIN: 40889942672418
  • Unit UDI/GTIN: 10889942672417
  • Lot Number: 22JBE355
  • b. WOUND PACK
  • Item Number: DYNJ80201A
  • Case UDI/GTIN: 40195327171538
  • Unit UDI/GTIN: 10195327171537
  • Lot Number: 22IBE619

Distribution

Distributed nationwide across the United States.

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