FDA Device recall Z-1833-2021
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- FDA Device
- Class I
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class I recall of DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 by Deroyal Industries, citing deRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bup….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-05-14 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Reason
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Identifiers
| code_info | Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2021%22
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