Arrow-Trerotola Over-The-Wire PTD Kit recall
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola…
Why was Arrow-Trerotola Over-The-Wire PTD Kit recalled?
The firm received reports indicating PTD tip separation during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number / UDI: 13F19M0129 / (01)10801902121315 (17)211130 (10)13F19M0129, Components: Code PT-65709-C, Lot number 13C19M0499; Lot Number / UDI: 13F20B0053 / (01)108019022121315 (17)220131 (10)13F20B0053, Components: Code PT-65709-C, Lot number 13C20A0970; Lot Number / UDI: 13F20C0595 / (01)10801902121315 (17)220331 (10)13F20C0595, Components: Code PT-65709-C, Lot number 13C20C2089; Code PT-65709-C, Lot number 13C20C2082; Lot Number / UDI: 13F20F0231 / (01)10801902121315 (17)220531 (10)13F20F0231, Components: Code PT-65709-C, Lot number 13C20F1139; Lot Number / UDI: 13F20G0361 / (01)10801902121315 (17)220731 (10)13F20G0361, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-C, Lot number 13C20G0228; Lot Number / UDI: 13F20K0632 / (01)10801902121315 (17)221031 (10)13F20K0632, Components: Code PT-65709-C, Lot number 13C20H1675; Lot Number / UDI: 13F21A0353 / (01)10801902121315 (17)221231 (10)13F21A0353, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-C, Lot number 13C20J2689; Lot Number / UDI: 13F21C0748 / (01)10801902121315 (17)230331 (10)13F21C0748, Components: Code PT-65709-C, Lot number 13C21C1696; Lot Number / UDI: 13F21D0721 / (01)10801902121315 (17)230430 (10)13F21D0721, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21C0326; Lot Number / UDI: 13F21E0823 / (01)10801902121315 (17)230531 (10)13F21E0823, Components: Code PT-65709-C, Lot number 13C21E0328; Lot Number / UDI: 13F21F1189 / (01)10801902121315 (17)230630 (01)13F21F1189, Components: Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-C, Lot number 13C21E0328
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola…
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 1265 units
- Distribution
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- Recall date
- February 23, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)