The Recall Desk
HighFDA (Devices)·Z-1069-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise

Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.

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: This is an FDA Class II recall of a medical device (surgical trays) where sterile blades may puncture sterile packaging, creating a risk of contamination. No illnesses or injuries have been reported, but the potential for harm exists in surgical applications where sterility is critical, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling sterile procedural trays used in surgical and medical procedures. The recall affects multiple tray types including breast biopsy packs, laparotomy packs, hemorrhoid packs, and rectal packs, totaling 200 cases (858 units).

The reason for the recall is that sterile blades contained within the procedural trays have the potential to puncture the outer foil layer of the sterile packaging. This could compromise the sterility of the trays and the instruments they contain.

The affected trays have been distributed worldwide, including to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific lot numbers are identified for each tray type.

The FDA has classified this as a Class II recall. No illnesses or injuries have been reported. Consumers and healthcare facilities with affected trays should contact Medline Industries for instructions on returning or replacing the products.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
Hazard
  • sterility-compromise
  • puncture
  • 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)

  • a. BREAST BIOPSY PACK-LF
  • Item Number: DYNJ0160598B
  • Case UDI/GTIN: 40889942051930
  • Unit UDI/GTIN: 10889942051939
  • Lot Number: 22IDB852
  • b. BREAST BIOPSY PACK
  • Item Number: DYNJ45087C
  • Case UDI/GTIN: 40195327044764
  • Unit UDI/GTIN: 10195327044763
  • Lot Number: 22JBO180
  • c. LAPAROTOMY PACK
  • Item Number: DYNJ55654B
  • Case UDI/GTIN: 40193489956727
  • Unit UDI/GTIN: 10193489956726
  • Lot Number: 22JDA974
  • d. BREAST PACK
  • Item Number: DYNJ56546C
  • Case UDI/GTIN: 40195327231164
  • Unit UDI/GTIN: 10195327231163
  • Lot Number: 22JBE655

Distribution

Distributed nationwide across the United States.

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