Cesarean Birth Drapes Recalled Due to Sticking Plastic Film
Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.
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 for a risk-of-harm medical device. The defective plastic film may prevent proper unfolding and application during surgical procedures, but no injuries or illnesses have been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 1,638 units of Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 (Lot Numbers 20LRR092 and 20MRR079). This product is intended to be used as a protective sterile covering during cesarean birth procedures to isolate the surgical site from contamination.
The plastic film used to manufacture the drapes is causing them to stick together. This defect may prevent the products from being properly unfolded and applied during surgery.
The affected drapes were distributed nationwide in both single sterile and bulk non-sterile configurations. Healthcare facilities and practitioners with affected lots should contact Cardinal Health 200, LLC regarding this recall.
The recalled product
- Product
- Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 1,638
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 (2)
- Lot Numbers: 20LRR092
- 20MRR079
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Cardinal Health 200, LLC 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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