The Recall Desk
HighFDA (Devices)·Z-1093-2023·Announced 2023-02-15

Sterile Surgical Trays Recalled for Blade Puncture Risk

Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.

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 medical device with genuine risk of harm—compromised sterility could lead to surgical site infections—but no illnesses or injuries have been reported. As a risk-of-harm product with no documented injury, this meets the criteria for High severity under FDA Class II.

Plain-English summary

Medline Industries is recalling multiple sterile procedural surgical trays used in gynecological, urological, and abdominal surgical procedures. The affected products include variants labeled as GYN ABD CDS, LAVH PROCEDURE, TAH CDS, and numerous other configurations.

The sterile blades packaged within these trays have the potential to puncture the outer foil layer of the sterile packaging. If this occurs, the sterility of the entire kit could be compromised, potentially exposing patients to contamination during surgery.

The recall affects approximately 2,154 units across 1,258 cases distributed worldwide to healthcare facilities in the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific lot numbers for each product variant have been identified by the FDA.

Healthcare facilities should verify whether they have received affected trays by checking the lot numbers provided in the FDA recall notice and take appropriate steps to prevent use of potentially compromised kits.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Procedural Trays
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 (20)

  • a. GYN ABD CDS
  • Item Number: CDS830215G
  • Case UDI/GTIN: 40889942110040
  • Unit UDI/GTIN: 10889942110049
  • Lot Number: 22IMD263
  • b. LAVH PROCEDURE
  • Item Number: CDS980754R
  • Case UDI/GTIN: 40195327008698
  • Unit UDI/GTIN: 10195327008697
  • Lot Number: 22JME637
  • c. TAH CDS
  • Item Number: CDS982249I
  • Case UDI/GTIN: 40193489651264
  • Unit UDI/GTIN: 10193489651263
  • Lot Number: 22JBM626
  • 22JBK303
  • d. CUH LITHOTOMY CDS
  • Item Number: CDS983207M
  • Case UDI/GTIN: 40195327164608
  • Unit UDI/GTIN: 10195327164607

Distribution

Distributed nationwide across the United States.

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