The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1613-2022·Announced 2022-08-31

McKesson GYNECATH H/S Catheter Recalled Due to Temperature Excursions Prior to Delivery

McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.

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: This is an FDA Class II recall with no reported illnesses or injuries. However, it qualifies as a 'risk-of-harm product'—a medical device for internal use with potential functionality compromise. Although the hazard is theoretical (the source states temperature exposure 'may have impacted' effectiveness), the risk of catheter failure during clinical use justifies a High severity classification.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling GYNECATH H/S Catheters (Model 11-19610, 5 French size, 10-count boxes) because the product may have been exposed to temperatures higher than intended during storage prior to delivery, which may have compromised product effectiveness.

Facility temperature excursions occurred between June and August 2021. All affected product lots were received by customers between June 1 and September 30, 2021.

The recalled product was distributed nationwide throughout the United States. No illnesses or injuries have been reported related to this recall.

Customers and healthcare facilities who received this product during the affected timeframe should verify their receipt dates and lot numbers and contact McKesson Medical-Surgical Inc. for guidance on handling affected product.

The recalled product

Product
Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Gynecological Catheters
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 (5)

  • GTIN: a. 20612479161539
  • 30612479162472 BX
  • 40612479161571 CS. b. 20612479161546
  • 30612479162489 BX
  • 40612479161588 CS

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.

See all 55 products in this recall →

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