Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit
FDA Recall Z-1051-2023 · Posted 2023-02-01
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Reason for Recall
Firm Action
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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