The Recall Desk
HighFDA (Devices)·Z-1083-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging

Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.

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 a risk-of-harm medical device recall where sterile procedural trays could have compromised packaging integrity due to blade puncture, potentially affecting sterility. No injuries or illnesses have been reported, making the hazard theoretical but significant for patient safety.

Plain-English summary

Medline Industries, LP is recalling specific lots of sterile procedural trays, including the MAJOR CDS-LF, BURN PACK-LF, BURN PACK, and SMALL BURN models. The recall affects approximately 100 cases containing 156 units.

Sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging during manufacturing, storage, or handling. A compromised outer foil layer may allow the internal contents to become contaminated, which could affect the sterility and safety of the trays when used in medical procedures.

The affected trays have been distributed worldwide, including throughout the United States and to Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates. Specific lot numbers and product identifiers are listed on the FDA recall notice.

No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and medical professionals who have received affected trays should contact Medline Industries for instructions regarding the recalled products.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Procedural Trays
Hazard
  • blade-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. MAJOR CDS-LF
  • Item Number: CDS983861D
  • Case UDI/GTIN: 40193489524353
  • Unit UDI/GTIN: 10193489524352
  • Lot Number: 22JDB004
  • b. BURN PACK-LF
  • Item Number: DYNJ0781678S
  • Case UDI/GTIN: 40193489226349
  • Unit UDI/GTIN: 10193489226348
  • Lot Number: 22IMC056
  • c. BURN PACK
  • Item Number: DYNJ82534
  • Case UDI/GTIN: 40195327198504
  • Unit UDI/GTIN: 10195327198503
  • Lot Number: 22HBI219
  • d. SMALL BURN
  • Item Number: DYNJ901793L
  • Case UDI/GTIN: 40193489955065
  • Unit UDI/GTIN: 10193489955064
  • Lot Number: 22KBB743

Distribution

Distributed nationwide across the United States.

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