Busse recalls surgical instrument trays containing recalled gloves
Busse Hospital Disposables is recalling surgical instrument trays that contained recalled Covidien Devon Light Gloves.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update for the incorporated gloves, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling SET UP PACK Surgical Instrument Trays (REF/Catalog No. 6250R1). The recall involves 82 cases distributed in Pennsylvania, Florida, and Virginia.
The recall was initiated because the surgical trays contained Covidien Devon Light Gloves that were subject to a labeling update. Busse had incorporated these affected gloves into the kits and distributed them before receiving the recall notification from the glove manufacturer.
Healthcare facilities and consumers should stop using the affected surgical instrument trays and contact the manufacturer for further instructions. The affected lots have expiration dates ranging from May 2017 to November 2017.
The recalled product
- Product
- SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
- Hazard
- Affected units
- 82
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 (9)
- Lot Number 1530330
- Exp. Date November 2017
- Lot Number 1530241
- Exp. Date September 2017
- Lot Number 1530095
- Lot Number 1431734
- Exp. Date August 2017
- Lot Number 1431066
- Exp. Date May 2017
Distribution
Part of a larger recall action
This product is one of 3 recalled by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables 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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