Recall Z-2397-2020
Angiodynamics, Inc. · initiated May 4, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051 H96560M0367061 H96560M05019111 H96560M0501981 H96560M1201961 H96560M1201971 H96560M12202101 H96560M12202111 H96560M12202121 H96560M1303151 H96560M1303171 H96560M1303191 H96560M13184101 H96560M13184111 H96560M1318491 H96560M1401411 H96560M1401421 H96560M1401431 H96560M1401441 H96560M1406061 H96560M1406071 H96560M1633931 H96560M1803441 H96560M1803451 H96560M18157111 H96560M18157121 H96560M1841151 H96560M1841161 H96560M1841171 H96560M1907131 H96560M1907141 H96560M2204441 H96560M2208511 H96560M2208521 H96560M2322421 H96560M2500961 H96560M2500971 H96560M610115911 H96560M610901011 H96560M611025121 H96560M611025131 H96560M611052821 H96560M611056021 H96560M611056031 H96560M611095821 H96560M611095831 H965PKM030667S1 H965PKM120451S1 H965PKM1220226S1 H965PKM1300011S1 H965PKM1303119S1 H965PKM131935S1 H965PKM150124S1 H965PKM150125S1 H965PKM150127S1 H965PKM220851S1 H965PKM220854S1 H965PKM3092662S1 H965PKM61040701S1 H965PKM61066141S1 H965PKM61095321S1 H965PKM61095324S1 Cat. No. 60M0116210 60M011629 60M013353 60M013421 60M019881 60M022474 60M022475 60M033562 60M036704 60M036705 60M036706 60M0501911 60M050198 60M120196 60M120197 60M1220210 60M1220211 60M1220212 60M130315 60M130317 60M130319 60M1318410 60M1318411 60M131849 60M140141 60M140142 60M140143 60M140144 60M140606 60M140607 60M163393 60M180344 60M180345 60M1815711 60M1815712 60M184115 60M184116 60M184117 60M190713 60M190714 60M220444 60M220851 60M220852 60M232242 60M250096 60M250097 60M61011591 60M61090101 60M61102512 60M61102513 60M61105282 60M61105602 60M61105603 60M61109582 60M61109583 PKM030667S PKM120451S PKM1220226S PKM1300011S PKM1303119S PKM131935S PKM150124S PKM150125S PKM150127S PKM220851S PKM220854S PKM3092662S PKM61040701S PKM61066141S PKM61095321S PKM61095324S
Codes / lots: Lots 5502064 5499646 5537999* 5470193 5482411 5491837 5498227 5519222 5523176 5534734 5544000 5574435 5583228 5468490 5485176 5525973 5552143 5569544 5476092 5482007 5474457 5498239 5513077 5532408 5555127 5574431* 5465977 5474459 5491848 5513071 5534738 5559194 5576291* 5470199 5480504 5491841 5513063 5528679 5566358 5576283 5498237 5546409 5468510 5487221 5528681 5537991 5566360 5574447 5586266 5587813 5465983 5474461 5487219 5491856 5502075 5519230 5546399 5555117 5574427 5587267 5530190 5460247 5468506 5478056 5498235 5519224 5530200 5546405 5557541 5569536 5574437 5578568 5488823 5502081 5465979 5468518 5485174 5488829 5502073 5519228 5530187 5548446 5559211 5566366 5574429 5578562 5583236 5474465 5546403 5468494 5474455 5485180 5502067 5525966 5537993 5555121 5559200 5566368 5578551 5488821 5496910 5569546 5585539* 5472110 5480506 5487225 5498231 5505007 5523171 5532396 5555131 5559204 5567557 5576293 5583232 5588904 5491844 5548431 5465975 5478054 5502060* 5530198* 5463223 5468502 5502058* 5471177 5484653 5490779 5499462 5497832 5496904 5502069 5532406 5559198 5588906* 5468498 5491846 5513056 5525993 5530194 5538001 5543992 5548448 5555133 5564678 5567555* 5580574* 5477981…
Reason for recall
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
FDA-determined cause: Process control
Action taken
The firm distributed URGENT VOLUNTARY MEDICAL DEVICE RECALL letters to affected customers on May 4, 2020. Customers were instructed to segregate and return affected devices to AngioDynamics, and to complete and return the reply verification tracking form provided with the recall notification. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. The letter included instructions on packaging and returning the recalled product.
Details
- Recall number
- Z-2397-2020
- Initiated
- May 4, 2020
- Terminated
- August 23, 2023
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 119723 eaches total
- Distribution
- US Nationwide distribution.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2395-2020 Class II | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-2396-2020 Class II | BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-2398-2020 Class II | BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |