Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or… — Class II medical device recall Z-1064-2016
Terminated recall by Arrow International Inc, reported 2016-03-16, distributed nationwide. Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products
| Recall number | Z-1064-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2016-01-12 |
| Classified | 2016-03-07 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 56,521 units |
| Reason classes | sterility |
| Lot numbers | 14F13G0058, 14F13G0062, 14F13G0104, 14F13G0155, 14F13G0157, 14F13G0229, 14F13H0125, 14F13H0127, 14F13H0140, 14F13H0221, 14F13H0288, 14F13H0292, 14F13H0412, 14F13H0421, 14F13J0038, 14F13J0045, 14F13J0151, 14F13J0267, 14F13K0066, 14F13K0108, 14F13K0171, 14F13K0175, 14F13K0334, 14F13L0012, 14F13L0070, 14F13L0105, 14F13L0243, 14F13M0040, 14F13M0045, 14F14A0132, 14F14A0309, 14F14A0310, 14F14A0420, 14F14A0423, 14F14A0428, 14F14A0435, 14F14B0161, 14F14B0167, 14F14B0295, 14F14B0305 and 330 more |
| Model numbers | CL-07035, CL-07635, CL-07735, CL-07835 |
Product
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. Rx only. The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
Reason for recall
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
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-1064-2016. 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.