The Recall Desk
HighFDA (Devices)·Z-1067-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Puncture Risk

Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.

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 recall with no reported injuries, illnesses, or hospitalizations. The source explicitly states the blade puncture is a 'potential' hazard, indicating a theoretical risk rather than confirmed harm. Score 3 applies as a risk-of-harm product where injury has not been reported.

Plain-English summary

Medline Industries, LP is recalling sterile procedural trays used in various surgical procedures. The recalled trays contain sterile blades that have the potential to puncture the outer foil layer of the sterile packaging.

The affected products have been distributed worldwide to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates. Approximately 12,964 cases containing 23,379 units are affected by this recall.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART C
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
Hazard
  • 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 (20)

  • a. EP LAB PACEMAKER PACK
  • Item Number: 00-401893L
  • Case UDI/GTIN: 40195327127887
  • Unit UDI/GTIN: 10195327127886
  • Lot Number: 22JMC769
  • b. OPEN HEART CDS
  • Item Number: CDS840016AD
  • Case UDI/GTIN: 40193489741842
  • Unit UDI/GTIN: 10193489741841
  • Lot Number: 22KBB889
  • c. OPEN HEART CDS
  • Item Number: CDS840023T
  • Case UDI/GTIN: 40193489682060
  • Unit UDI/GTIN: 10193489682069
  • Lot Number: 22JBU353
  • 22JBT770
  • d. AAA CDS
  • Item Number: CDS840076AC
  • Case UDI/GTIN: 40195327209620
  • Unit UDI/GTIN: 10195327209629

Distribution

Distributed nationwide across the United States.

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