Busse Breast Pack Surgical Instrument Tray Recalled for Labeling Update
Busse Hospital Disposables is recalling Breast Pack Surgical Instrument Trays because they contained 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 driven by a labeling update for an incorporated component, which aligns with the rubric criterion for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling the Breast Pack, Surgical Instrument Tray, REF/Catalog No. 5406. The recall involves 35 cases of the sterile, prescription-only device distributed in Pennsylvania, Florida, and Virginia.
The recall was initiated because the kits contained Covidien Devon Light Gloves that were subject to a labeling update issued by Covidien. Busse had incorporated these affected gloves into the kits and distributed them before receiving the recall notification. The affected lots are 1230323, 1230387, and 1231616, all with an expiration date of December 2016.
Healthcare facilities and consumers should stop using the affected Breast Pack Surgical Instrument Trays and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
- Hazard
- Affected units
- 35
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 1230323
- Exp. Date December 2016
- Lot Number 1230387
- Lot Number 1231616
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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