The Recall Desk
HighFDA (Devices)·Z-1623-2022·Announced 2022-08-31

Medical device recall for temperature exposure during storage

McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.

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 Class II FDA recall of medical devices where temperature exposure may have reduced product effectiveness. No illnesses or injuries have been reported, and the hazard remains theoretical, placing this in the 'High' category as a risk-of-harm product with unconfirmed impacts.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling multiple medical device products manufactured by Derma Sciences, Inc. The recalled items include NG Strip nasal tube fasteners (772 units), Surgitube gauze bandages (9 units), Surgilast tube netting (1 unit), and Surgitube/Surgigrip applicators (1 unit).

The products were exposed to temperature excursions ranging from June 2021 through August 2021 prior to delivery. This exposure to higher-than-normal temperatures may have impacted the products' effectiveness, reducing their ability to function as intended.

All units received between June 1, 2021, and September 30, 2021, are affected by this recall. The products were distributed nationwide throughout the United States.

Consumers and healthcare facilities with affected units should contact McKesson Medical-Surgical Inc. for replacement or refund information. Units should not be used if they were received during the affected timeframe.

The recalled product

Product
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Wound Care / Medical Supplies
Hazard
  • temperature-excursion

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 (1)

  • a. GTIN: 00753567101252

Distribution

Distributed nationwide across the United States.

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