DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD… — Class II medical device recall Z-1963-2020
Terminated recall by DeRoyal Industries Inc, reported 2020-05-20, distributed in FL, MA, MD, MN, ND, NY, RI, TN. DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in
| Recall number | Z-1963-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2020-04-24 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-05-26 |
| Distributed | FL, MA, MD, MN, ND, NY, RI, TN |
| Lot numbers | 49896872, 49935860, 49989657, 50110742, 50129064, 50129072, 50129726, 50275125, 50375468, 50381438, 50477253, 50570141, 50601672, 50612902, 50630967, 50784528, 50829255, 50879543, 50905238, 50919891, 51006728, 51006787, 51008408, 51030197, 51220521, 51252849, 51284787, 51347371, 51382467, 51434765, 51458994, 51473449, 51556261, 51602562, 51604074, 51733028, 51788951, 51791631, 51791800, 51836975 and 15 more |
| Model numbers | 89-9370.01 |
| Expiration dates | 2020-07-01, 2020-10-01, 2021-01-01, 2021-02-01, 2021-04-01, 2021-05-01, 2021-08-01, 2021-10-01, 2021-11-01, 2021-12-01, 2022-01-01, 2022-02-01, 2022-04-01 |
Product
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. Port Pack Pgybk, 89-8748.03 f. Port Pack Pgybk, 89-8748.04 g. Central Line Pack Pgybk, 89-8448.02 h.CV Insertion Kit II Pgybk, 89-9417.03 I. CV Insertion Kit II Pgybk, 89-9417.04 j. Right Heart Introducer Pgybk, 89-8495.04 k. Vein Pack Pgybk, 89-10400.01
Reason for recall
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
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-1963-2020. 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.