The Recall Desk
HighFDA (Devices)·Z-1063-2023·Announced 2023-02-15

Medline Sterile Procedural Trays recalled due to packaging defect risk

Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising 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 an FDA Class II medical device recall without reported hospitalizations or injuries. The potential for sterile blades to puncture protective packaging creates a sterility assurance risk, fitting the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Sterile Procedural Trays labeled as PAIN SERVICE PACK-LF and LOCAL BASIC. The recall affects 12 cases (60 units) distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

The sterile blades contained within these procedural trays have the potential to puncture the outer foil layer of the sterile packaging. This compromise to the sterile packaging could result in contamination and loss of sterility assurance.

Affected lot numbers are: PAIN SERVICE PACK-LF (Lot 22HDC372) and LOCAL BASIC (Lots 22HBQ831 and 22HBO949). Healthcare facilities and users should immediately quarantine and cease use of the recalled products and contact Medline Industries for replacement.

The recalled product

Product
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Tray
Hazard

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 (11)

  • a. PAIN SERVICE PACK-LF
  • Item Number: DYNJ0101290D
  • Case UDI/GTIN: 40193489345552
  • Unit UDI/GTIN: 10193489345551
  • Lot Number: 22HDC372
  • b. LOCAL BASIC
  • Item Number: DYNJ34418L
  • Case UDI/GTIN: 40193489969277
  • Unit UDI/GTIN: 10193489969276
  • Lot Number: 22HBQ831
  • 22HBO949

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · blade puncture

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