The Recall Desk
HighFDA (Devices)·Z-1089-2023·Announced 2023-02-15

Sterile surgical trays recalled due to packaging puncture risk

MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were 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: FDA Class II medical device recall involving sterile packaging defect on surgical instruments. No illnesses or injuries reported. Meets rubric criterion for High: a risk-of-harm product where injury has not yet been reported, as the potential for packaging breach could lead to contamination if sterility is compromised.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling six models of sterile surgical trays for gynecological and obstetric procedures: GYN LAPAROTOMY HARPER PACK-LF, OB GYN LAP PACK-LF, VAGINAL HYSTERECTOMY PACK, DELTA PACK, MAJOR VAGINAL-LF, and GYN LAPAROSCOPY II. The recall affects 194 cases containing 508 units in total.

The recall was initiated because sterile blades contained within the surgical trays have the potential to puncture the outer foil layer of the sterile packaging. Such a puncture could compromise the package's ability to maintain sterility.

The affected trays were distributed worldwide, including throughout the United States and internationally to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

No illnesses or injuries have been reported associated with this recall.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical instruments
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. GYN LAPAROTOMY HARPER PACK-LF
  • Item Number: DYNJ0160684D
  • Case UDI/GTIN: 40193489205528
  • Unit UDI/GTIN: 10193489205527
  • Lot Number: 22JDA531
  • 22IDB178
  • 22IDA705
  • b. OB GYN LAP PACK-LF
  • Item Number: DYNJ43413C
  • Case UDI/GTIN: 40193489901185
  • Unit UDI/GTIN: 10193489901184
  • Lot Number: 22JBS296
  • c. VAGINAL HYSTERECTOMY PACK
  • Item Number: DYNJ47624B
  • Case UDI/GTIN: 40193489735360
  • Unit UDI/GTIN: 10193489735369
  • Lot Number: 22KBB429
  • 22IBE503
  • d. DELTA PACK
  • Item Number: DYNJ59117A

Distribution

Distributed nationwide across the United States.

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