FDA Device recall Z-0637-2018
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy by Deroyal Industries, citing 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' thro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0637-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-22 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Deroyal Industries |
| Distribution | NY |
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
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.
Identifiers
| code_info | Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2018%22
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