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FDA Medical Device Recalls (openFDA)

Bard Peripheral Vas: Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P).

Recall number
Z-1879-2009
Recalling firm
Bard Peripheral Vas
Product
Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P).
Status
Terminated
Initiated
2009-03-26
Posted
2009-08-26
Terminated
2012-04-02
Reason
Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
Root cause
Process control
Action
Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.
Quantity
7,540
Distribution
Worldwide Distribution.
Lot, serial or model codes
Lot Numbers: HUSA1667, HUSA1668, HUSA1669, HUSA1670, HUSA1671, HUSC1173, HUSC1174, HUSC1175, HUSC1176, HUSC1527, HUSC1528, HUSC1529, HUSC1530, HUSC1531, HUSC1532. HUSC1533, HUSC1535, HUSC1536, HUSC1537, HUSC1072, HUSC1078, HUSC1859, HUSC1074, HUSC1074, HUSC1075, HUSC1076, HUSC1077, HUSD2650, HUSD2651, HUSD2652, HUSD2653, HUSD2654, HUSD2655, HUSD2656, HUSG0389, HUSG0390, HUSG0391, HUSG0591, HUSG0592, HUSG0593, HUSG0594, HUSG0595, HUSG0596, HUSI1060, HUSI1061, HUSI1062, HUSI1063, HUSI1064, HUSJ0192, HUSJ0193, HUSJ0194, HUSJ 0195 and HUSJ0196.
510(k) numbers
["K082681"]
PMA numbers
not on file
Product code
DWF
Firm FEI
3000131337
Firm city
Tempe
Firm state
AZ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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