The Recall Desk
HighFDA (Devices)·Z-1066-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Recalled Over Blade Puncture Risk

Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.

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 FDA Class II recall involves sterile medical devices used in high-risk cardiac and surgical procedures. No illnesses or injuries have been reported. The hazard is theoretical—sterile blades have the potential to puncture sterile packaging—which fits 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 cardiac catheterization, angiography, pacemaker insertion, and open heart procedures. The affected products include multiple tray types such as Cardiac Cath Pack-LF, Angiography-NS-LF, EP Basic Set Up Pack, Implant Pack-LF, Port Pacemaker Insertion Pack, Open Heart Pack, Lap Basin Tray, and Angio models.

Sterile blades contained within these kits have the potential to puncture the outer foil layer of the sterile packaging. If the packaging is breached, the sterility of the medical devices could be compromised.

The recall affects 314 cases (719 units total) that were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Multiple lot numbers are included in the recall, with specific product codes and lot information available from the FDA at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1066-2023 (Recall Number Z-1066-2023).

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays / Sterile Kits
Hazard
  • blade-puncture
  • contamination

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. CARDIAC CATH PACK-LF
  • Item Number: DYNJ0368386D
  • Case UDI/GTIN: 40889942060246
  • Unit UDI/GTIN: 10889942060245
  • Lot Number: 22IMD669
  • b. ANGIOGRAPHY-NS-LF
  • Item Number: DYNJ24913N
  • Case UDI/GTIN: 40195327127368
  • Unit UDI/GTIN: 10195327127367
  • Lot Number: 22JBC783
  • c. EP BASIC SET UP PACK
  • Item Number: DYNJ27920D
  • Case UDI/GTIN: 40884389855349
  • Unit UDI/GTIN: 10884389855348
  • Lot Number: 22IBS859
  • d. IMPLANT PACK-LF
  • Item Number: DYNJ43426C
  • Case UDI/GTIN: 40195327255313
  • Unit UDI/GTIN: 10195327255312
  • Lot Number: 22IBO525

Distribution

Distributed nationwide across the United States.

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