The Recall Desk
HighFDA (Devices)·Z-1632-2022·Announced 2022-08-31

Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage

Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

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 risk-of-harm to a medical product due to temperature-induced effectiveness loss. No illnesses or injuries reported, and the impact remains theoretical rather than confirmed, fitting the rubric criterion for risk-of-harm products without reported harm.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling Morrison Medical OB Kits (Catalog #0967NL, GTIN 00647921096707) distributed nationwide. The product is a hard-pack obstetric kit containing 16 units sealed in cardboard boxes.

The recall was initiated because facility temperature excursions occurred from June through August 2021 prior to delivery. Exposure to higher temperatures may have impacted the product's effectiveness. All lots received between June 1 and September 30, 2021 are affected by this recall.

Healthcare facilities and medical professionals who received affected kits should verify the lot numbers and dates against the recall notice. Contact Mckesson Medical-Surgical Inc. for guidance on returns, replacements, or alternative products.

The recalled product

Product
MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-exposure
  • effectiveness-loss

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)

  • GTIN: 00647921096707

Distribution

Distributed nationwide across the United States.