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Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130...

FDA Device Recall #Z-0257-2018 — Class II — June 27, 2017

Recall Summary

Recall Number Z-0257-2018
Classification Class II — Moderate risk
Date Initiated June 27, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Terumo Cardiovascular Systems Corporation
Location Elkton, MD
Product Type Devices
Quantity 214146 units

Product Description

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.

Distribution Pattern

Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

Lot / Code Information

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 74369 TN16 74369 TN16 74369 TP07 74369 TP07 74369 TP14 74369 TP14 74369 TP14 74369 UA25 74369 UA25 74369 UA25 74369 UA25 74369 UC01 74369 UC01 74369 UC01 74369 UC01 74369 UC22 74369 UC22 74369 UC22 74369 UC22 74369 UC29 74369 UC29 74369 UC29 74369 UC29 74369 UD28 74369 UD28 74369 UD28 74369 UE04 74369 UE04 74369 UE04 74369 UE04 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UG06 74369 UG06 74369 UG06 74369 UG06 74369 UG06 74369 UG20 74369 UG20 74369 UG20 74369 UG20 74369 UG20 74369 UH18 74369 UH18 74369 UH18 74369 UK01 74369 UK01 74369 UK01 74369 UK01 74369 UK01 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UL12 74369 UL12 74369 UL12 74369 UL12 74369 UL26 74369 UL26 74369 UL26 74369 UL26 74369 UL26 74369 UM03 74369 UM03 74369 UM03 74369 UM03 74369 UM24 74369 UM24 74369 UM24 74369 UM24 74369 UM24 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UN28 74369 UN28 74369 UN28 74369 UN28 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 VA02 74369 VA02 74369 VA02 74369 VA02 74369 VA02 74369 VA09 74369 VA09 74369 VA09 74369 VA09 74369 VA09 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VC06 74369 VC06 74369 VC06 74369 VC06 74369 VC06 74369 VD06 74369 VD06 74369 VD06 74369 VD06 74369 VD06T 74369 VD06T 74369 VD06T 74369 VD06T 74369 VD06T 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE10 74369 VE10 74369 VE10 74369 VE10 74369 VE10 74369 VE24 74369 VE24 74369 VE24 74369 VE24 74369 VE24 74369 VF22T 74369 VF22T 74369 VF22T 74369 VF22T 74369 VF22T 71156 TK10 71156 TK10 71156 TK10 71156 TK10 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TM12 71156 TM12 71156 TM12 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71551-02 UN28 71551-02 UN28 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TK10 71413 TK10 71413 TK10 71413 TK10 71413 TK10 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 UA04 71413 UA04 71413 UA04 71413 UA04 71413 UA04 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UG27 71413 UG27 71413 UG27 71413 UG27 71413 UK08 71413 UK08 71413 UK08 71413 UK08 71413 UK22 71413 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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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