Busse Carpal Tunnel Surgical Packs Recalled Due to Labeling Update
Busse Hospital Disposables is recalling Carpal Tunnel Packs because they contained Devon Light Gloves subject to a labeling update.
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 is driven by a labeling update rather than a reported injury or high-risk contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling Carpal Tunnel Packs, Surgical Instrument Tray, REF/Catalog No. 3366. The recall involves 14 cases of the sterile, prescription-only surgical trays.
The recall was initiated because the packs contained Devon Light Gloves manufactured by Covidien. Covidien issued a labeling update for these gloves, and Busse had incorporated the affected gloves into the kits and distributed them before receiving the recall notification.
The affected units were distributed to Pennsylvania, Florida, and Virginia. The specific lots involved are Lot Number 1230783 (Exp. Date February 2017) and Lot Number 1330825 (Exp. Date April 2018). Healthcare facilities should stop using these specific lots and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
- Hazard
- Affected units
- 14
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 (4)
- Lot Number 1230783
- Exp. Date February 2017
- Lot Number 1330825
- Exp. Date April 2018
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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