CARPAL TUNNEL PACK — Class II medical device recall Z-0894-2017
Terminated recall by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, reported 2016-12-28, distributed in FL, PA, VA. Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected glo
| Recall number | Z-0894-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, Hauppauge, NY, United States |
| Recall initiated | 2016-11-15 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-06-21 |
| Distributed | FL, PA, VA |
| Quantity | 14 cases |
| Reason classes | labeling |
| Lot numbers | 1230783, 1330825 |
| Model numbers | 3366 |
| Expiration dates | 2017-02-20, 2018-04-20 |
Product
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Reason for recall
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0894-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.