Precision Delivery Set with Filter — Class II medical device recall Z-1100-2023
Ongoing recall by Quest Medical, Inc., reported 2023-02-15, distributed nationwide. Delivery Sets may have tubing that could become detached that could result in patient infection.
| Recall number | Z-1100-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quest Medical, Inc., Allen, TX, United States |
| Recall initiated | 2022-12-23 |
| Classified | 2023-02-07 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 13,900 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00634624911062, 00634624921412 |
| Lot numbers | 65826, 66069, PD06F/00634624911062/65824, PDT05CV2/00634624921412/66645 |
| Model numbers | PD06F, PDT05CV2 |
Product
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Reason for recall
Delivery Sets may have tubing that could become detached that could result in patient infection.
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-1100-2023. 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.