FDA Device recall Z-0257-2018
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130…
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0257-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-27 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | n/a |
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
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Identifiers
| code_info | SAFETY ALERT Lot Codes: US Distribution: Catalog Number Lot Code 74369 TH20…SAFETY ALERT Lot Codes: US Distribution: Catalog Number Lot Code 74369 TH20 74369 TH20 74369 TH27 74369 TH27 74369 TK10 74369 TL08 74369 TL08 74369 TL21 74369 TL21 74369 TM05 74369 TM05 74369 TM19 74369 TM19 74369 TM26 74369 TM26 74369 TM26 7436 |
|---|
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-0257-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.