DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk — Class II medical device recall Z-0363-2016
Terminated recall by DeRoyal Industries Inc, reported 2015-12-09, distributed in CT, MA, MO, NC. These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was
| Recall number | Z-0363-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2015-09-10 |
| Classified | 2015-12-02 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2018-06-22 |
| Distributed | CT, MA, MO, NC |
| Countries outside the US | KW |
| Quantity | 836 units |
| Reason classes | sterility, packaging |
| Lot numbers | 27369748, 27469087, 27964707, 28167081, 28207599, 28712544, 29929171, 30474952, 30984021, 31210924, 33091009, 34939471, 34952712, 35328356, 35428242, 35543822, 35549693, 35550352, 359097163, 35947501, 36068496, 36612412, 36660692, 36674648, 36813530, 36974376, 36987476, 37008882, 37057289, 37078506, 37086725, 37099609, 37109721, 37210095, 37217991, 37253124, 37325378, 37392319, 37401318, 37413132 and 14 more |
| Model numbers | 89-5792.10, 89-7626.02, 89-7626.03, 89-7750.02, 89-7750.03, 89-7859.01, 89-7859.02, 89-8440.01, 89-8440.02, 89-8514.02 |
Product
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
Reason for recall
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
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-0363-2016. 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.