FDA Recalls Premier Guard Drape Due to Sterility Compromise
The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or those with hospitalization reports, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the compromise of sterility in a surgical context is a significant hazard that aligns with the Severe classification for Class II medical device recalls where the risk is not merely theoretical but involves a breach of a critical safety barrier.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Premier Guard Drape, Sterile, manufactured by Covidien LLC. The recall is due to a breach in the sterile barrier, which compromises the sterility of the product. This drape is used in conjunction with RF Surgical Gauze detection systems, specifically the Verisphere (01-0035) and ArQ.Sphere (01-0044), to protect scanning devices from contamination during surgical procedures.
The affected product is identified by Item Number 01-0037. The recall covers 42,750 units distributed nationwide. The specific lot numbers affected range from 1410577-4 to 1605778.
Healthcare facilities and consumers should check their inventory for this specific item number and lot number range. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA advises that the use of non-sterile drapes in surgical settings can increase the risk of infection.
The recalled product
- Product
- Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 42,750
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)
- Lot Numbers: 1410577-4 to 1605778
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien 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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