Custom surgical kits containing TERUMO — Class II medical device recall Z-0257-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2017-12-27. Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (O
| Recall number | Z-0257-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2017-06-27 |
| Classified | 2017-12-18 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2019-07-16 |
| Countries outside the US | BE, CA, CO, GB, JP |
| Quantity | 214,146 units |
| Lot numbers | 63728-03, 64048-02, 64135, 64941-01, 65080-04, 65080-05, 65358, 65418-02, 65418-04, 65672-02, 65672-04, 66362, 66485, 66503, 66503-01, 66505, 70692-03, 70693-03, 70695-04, 70696-04, 70899-02, 71036, 71156, 71413, 71488-01, 71493, 71551-02, 71692, 71841-01, 71852-02, 73673-04, 73679-03, 73772-02, 73773-02, 73774-02, 73775-02, 73816-01, 73884-01, 74069, 74102 and 196 more |
| Model numbers | 131422-02, 2-01, 4-01, 62007-01, 62007-02, 62086-01, 62218, 62420-03, 62786-08, 62847, 63086, 63123, 63572-01, 63728-03, 63885-03, 63924-03, 63957-04, 64048-02, 64135, 643-01, 64388, 64521-02, 64522-03, 64523-02, 64619-02 and 475 more |
Product
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01 75037 75973 75308-01 75688 70571-06 75114-01 72755 73306 71180-01 73307 75163 75164 75787 75163-01 73055-02 75450 75451 75452 75453 75453-01 75999 75451-01 72481-01 75197 73968 75416 73648 71519-02 71801-01 72846 74163-02 74178-03 74986 75607 74162-01 74163-03 73454-01 71296-01 74924 73344-04 73500-04 74924-01 73143-02 76393 74248-01 73820-01 75261 75594 74022-01 66001-01 66004-01 74916 72736-02 B72736-02 70815 70815-01 70815-02 74356-02 73208-03 73001-02 73957-01 74460-01 70089-06 75168 75171 75240 74382-01 66467 70089-07 74965-03 75168-01 75240-01 66467-01 70089-08 73177 76006 73177-01 76038 75252-01 76316 75805-02 73346 76414 75790 75678 62007-01 66229 75075 62007-02 65382 75788 75788-01 70533-10 75936 75936-01 63123 72241 70148-02 70730 70772 74732 75090 75090-01 75090-02 75089-01 73468 74430 74921-02 75881 64523-02 64619-02 64522-03 64521-02 65560-03 64912-04 65560-04 71064 65570 71062-01 71061-02 71060-01 71962-04 71965-04 75948 71962-05 74401-01 74400-01 74399-02 75944 759
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (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-0257-2018. 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.