FDA Device recall Z-1038-2019
FilterFlow Suction Handle CH24, 20 eaches per sales unit
- FDA Device
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of FilterFlow Suction Handle CH24, 20 eaches per sales unit by Convatec, citing an internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1038-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-09 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Convatec |
| Distribution | US |
Product
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.
Reason
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Identifiers
| code_info | Product Code/REF Number: 504159; Lot Codes: 176482, 189027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1038-2019%22
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