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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 16
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.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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