Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK… — Class II medical device recall Z-0637-2018
Terminated recall by DeRoyal Industries Inc, reported 2018-02-28, distributed in NY. DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were
| Recall number | Z-0637-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2018-01-22 |
| Classified | 2018-02-16 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-08-19 |
| Distributed | NY |
| Quantity | 181 units |
| Reason classes | sterility |
| Lot numbers | 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903 |
| Model numbers | 89-5985.07 |
Product
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Reason for recall
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
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-0637-2018. 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.