The products involved in the recall are as follows. Additional detail about how to identify the affected products is available in the recall letter.
Product Code | Lot Number | Unique Device Identifier (UDI) # |
PT-12709-WC | 13F19K0564 | (01)20801902156758 (17)210930 (10)13F19K0564 |
13F20C0094 | (01)10801902121254 (17)220228 (10)13F20C0094 | |
13F20G0284 | (01)10801902121254 (17)220630 (10)13F20G0284 | |
13F20L0282 | (01)10801902121254 (17)221031 (10)13F20L0282 | |
13F21A0497 | (01)10801902121254 (17)221231 (10)13F21A0497 | |
13F21A0718 | (01)10801902121254 (17)230131 (10)13F21A0718 | |
13F21F1187 | (01)10801902121254 (17)230630 (10)13F21F1187 | |
13X21E0008 | (01)10801902121254 (17)230531 (10)13X21E0008 | |
PT-65709-HFWC | 13F19K0369 | (01)10801902121292 (17)210930 (10)13F19K0369 |
13F20A0323 | (01)108019022121292 (17)211231 (10)13F20A0323 | |
13F20B0139 | (01)10801902121292 (17)220131 (10)13F20B0139 | |
13F20C0594 | (01)10801902121292 (17)220331 (10)13F20C0594 | |
13F20F0083 | (01)10801902121292 (17)220531 (10)13F20F0083 | |
13F20F0230 | (01)10801902121292 (17)220531 (10)13F20F0230 | |
13F20F0577 | (01)10801902121292 (17)220630 (10)13F20F0577 | |
13F20H0756 | (01)10801902121292 (17)220831 (10)13F20H0756 | |
13F20K0849 | (01)10801902121292 (17)221031 (10)13F20K0849 | |
13F20L0283 | (01)10801902121292 (17)221031 (10)13F20L0283 | |
13F20M0182 | (01)10801902121292 (17)221231 (10)13F20M0182 | |
13F21A0498 | (01)10801902121292 (17)221231 (10)13F21A0498 | |
13F21B0158 | (01)10801902121292 (17)230131 (10)13F21B0158 | |
13F21C0747 | (01)10801902121292 (17)230331 (10)13F21C0747 | |
13F21E0555 | (01)108019021212292 (17)230430 (10)13F21E0555 | |
PT-65709-W | 13F19M0129 | (01)10801902121315 (17)211130 (10)13F19M0129 |
13F20B0053 | (01)108019022121315 (17)220131 (10)13F20B0053 | |
13F20C0595 | (01)10801902121315 (17)220331 (10)13F20C0595 | |
13F20F0231 | (01)10801902121315 (17)220531 (10)13F20F0231 | |
13F20G0361 | (01)10801902121315 (17)220731 (10)13F20G0361 | |
13F20K0632 | (01)10801902121315 (17)221031 (10)13F20K0632 | |
13F21A0353 | (01)10801902121315 (17)221231 (10)13F21A0353 | |
13F21C0748 | (01)10801902121315 (17)230331 (10)13F21C0748 | |
13F21D0721 | (01)10801902121315 (17)230430 (10)13F21D0721 | |
13F21E0823 | (01)10801902121315 (17)230531 (10)13F21E0823 | |
13F21F1189 | (01)10801902121315 (17)230630 (01)13F21F1189 | |
PT-65709-WC | 13F19J0656 | (01)20801902156741 (17)210930 (10)13F19J0656 |
13F19K0342 | (01)20801902156741 (17)210930 (10)13F19K0342 | |
13F19K0368 | (01)10801902121308 (17)210930 (10)13F19K0368 | |
13F20C0596 | (01)10801902121308 (17)220331 (10)13F20C0596 | |
13F20F0081 | (01)10801902121308 (17)220531 (10)13F20F0081 | |
13F20F0229 | (01)10801902121308 (17)220531 (10)13F20F0229 | |
13F20F0509 | (01)10801902121308 (17)220531 (10)13F20F0509 | |
13F20F0578 | (01)10801902121308 (17)220630 (10)13F20F0578 | |
13F20G0177 | (01)10801902121308 (17)220630 (10)13F20G0177 | |
13F20G0566 | (01)10801902121308 (17)220630 (10)13F20G0566 | |
13F20H0531 | (01)10801902121308 (17)220831 (10)13F20H0531 | |
13F20J0379 | (01)10801902121308 (17)220831 (10)13F20J0379 | |
13F20L0514 | (01)10801902121308 (17)221031 (10)13F20L0514 | |
13F21A0354 | (01)10801902121308 (17)221231 (10)13F21A0354 | |
13F21C0081 | (01)10801902121308 (17)230228 (10)13F21C0081 | |
13F21C0749 | (01)10801902121308 (17)230331 (10)13F21C0749 | |
13F21D0870 | (01)10801902121308 (17)230430 (10)13F21D0870 | |
13F21E0415 | (01)10801902121308 (17)230430 (10)13F21E0415 | |
13F21F1188 | (01)10801902121308 (17)230630 (10)13F21F1188 |
If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes. In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. The lumen component is radio-opaque.
As of
On
Consumers who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to
Consumers with questions may contact the company at 1-866-396-2111;
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the
© 2021
Source:
Vice President, Investor Relations and
Vice President, Investor Relations
investor.relations@teleflex.com
610-948-2836
Source:
2021 GlobeNewswire, Inc., source