FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise
The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a medical device with a compromised sterile barrier (risk of infection) falls under the 'Severe' category, as it represents a significant risk of harm even if specific injury reports are not detailed in the brief source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Premier Guard Sterile Drapes used with the Blair-Port Wand and Blair-Port Wand X. The recall is due to a breach in the sterile barrier, which compromised the sterility of the product. These drapes are used in conjunction with RF Surgical Gauze detection systems to protect scanning devices from contamination during surgical procedures.
The recall involves 1,111,600 units of the product, identified by Item Number 01-0020. The affected lot numbers range from 1112351 to 1609891. The product was distributed nationwide by the recalling firm, Covidien LLC.
Healthcare facilities and consumers should stop using the affected drapes immediately. Users should contact their supplier or the manufacturer for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 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
- 1,111,600
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: 1112351 to 1609891
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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