The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman… — Class I medical device recall Z-0478-2016
Terminated recall by Stryker Sustainability Solutions, reported 2016-01-13, distributed in AK, CA, FL, IN, NC, NY, OR, WI. Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to rece
| Recall number | Z-0478-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Phoenix, AZ, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-09-28 |
| Distributed | AK, CA, FL, IN, NC, NY, OR, WI |
| Quantity | 34 devices |
| Lot numbers | 295397U, 331621U, 374044U, 394431U, 406125U, 406131U, 410982U, 412655U, 415094U, 422060U, 519812U, 7718289U, 838193U |
| Model numbers | G03974 |
Product
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
Reason for recall
Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
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-0478-2016. 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.