ARROW recallZ-0629-2022 · Teleflex Medical Inc · initiated Jan 11, 2022

Why it was recalled

The firm received reports indicating PTD tip separation during use.

FDA root cause category: Process change control

What the company is doing

Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope to Teleflex. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form. 4. If you have further distr

Recall details

Recall number

Z-0629-2022

Status

Terminated

Initiated by the company

Jan 11, 2022

Posted by the FDA

Feb 15, 2022

Recalling firm

Teleflex Medical Inc

Quantity

14583 units

Product code

QEW

FDA submissions

K011056

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.

Product description

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• ARROW IPN035902

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall12 reports
• ARROW IPN920364

  Teleflex Incorporated · Catheter, embolectomy
  1 recall0 reports

Product lines

• ARROWTeleflex Incorporated · 1,494 models · 9,043 reports · 62 recalls

Other devices under the same FDA submission

9 devices cleared under K011056 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ARROW IPN036253

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall1 report
• ARROW IPN036254

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall1 report
• ARROW IPN036249

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall0 reports
• ARROW IPN036250

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall0 reports
• ARROW IPN036252

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall0 reports
• ARROW IPN036255

  Teleflex Incorporated · CATHETER, EMBOLECTOMY
  1 recall0 reports
• ARROW IPN920363

  Teleflex Incorporated · Catheter, embolectomy
  1 recall0 reports
• ARROW IPN920365

  Teleflex Incorporated · Catheter, embolectomy
  1 recall0 reports
• ARROW IPN914602

  Teleflex Incorporated · Catheter, embolectomy
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89390).

• Z-0623-2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thro…
• Z-0624-2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percuta…
• Z-0625-2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PT…
• Z-0626-2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutane…
• Z-0627-2022 · Terminated
  Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) C…
• Z-0628-2022 · Terminated
  5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-010…