Agency classClass IIOur severity:Severe FDA (Devices)·Z-1408-2017·Announced 2017-03-15

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.

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, 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
Hazard: sterility-compromise
infection-risk
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.

See all 2 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise