FilterFlow Suction Handle CH24 — Class II medical device recall Z-1038-2019
Ongoing recall by ConvaTec, Inc, reported 2019-03-27, distributed nationwide. An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
| Recall number | Z-1038-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IS, IT, KE, KR, KW, LB, NL, NO, NZ, PL, QA, SE, SG, SK, TR, VN, ZA |
| Quantity | 124,000 units |
| Reason classes | sterility |
| Lot numbers | 176482, 189027 |
| Model numbers | 504159 |
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 for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
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-1038-2019. 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.