Bard Access Systems Inc.: PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

Recall number

Z-0536-2018

Recalling firm

Bard Access Systems Inc.

Product

PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

Status

Terminated

Initiated

2017-12-28

Posted

2018-02-06

Terminated

2021-06-14

Reason

Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.

Root cause

Labeling design

Action

Customers were notified via letter on approximately 12/28/2017. Instructions include a reminder that if additional extension sets are attached to the luers of the catheters, they should be appropriately secured as per hospital recommended securement protocol, to refrain from having unsupported extension sets that could put stress on the luer extension leg junction of the catheter, and to notify customers if the product was further distributed. Also, the notification contained a statement that Bard Access is in the process of updating their Instructions for Use to include a statement regarding the importance of properly securing additional extension sets per hospital recommended securement protocol. On 04/11/2018, the recall was expanded and customers were notified via letter, which explained that the previous recall has been expanded to involve return of affected product as well as include product distributed from February 2017 through March 2018. Instructions included to examine inventory for affected product, quarantine and immediately discontinue distribution of the product, complete and return the Business Recall Response Form, arrange for the return of affected product, and notify customers if the product has been further distributed. For distributors, Bard Access Systems requested a customer list so that they could notify their customers.

Quantity

53,699 units total

Distribution

Distribution US nationwide.

Lot, serial or model codes

Product Code (Lot/Serial No.): S1274108D (REBN2334), S9274108D (REBN2336), S3274108PD (REBP1471), S3274335 (REBP1580), S3274355 (REBP1581), S3274355P (REBP1582), S3274335P (REBP1583), S1274108PD (REBP1971), S1274108 (REBQ1883), S3274355 (REBQ1884), S3274335 (REBQ1885), S3274108D (REBQ1886), S1274108D (REBQ1887), S9274108PD (REBQ1888), S0274108PD (REBQ1889), S3274335P (REBQ1890), S1274118 (REBQ1891), S9274108D (REBQ1892), S1274108D (REBR0160), S1274108D (REBN1883), S1173108D (REBN2329), S9173108D (REBN2332), S1274108PD (REBN2378), S9274108PD (REBN2379), S1173108PD (REBP0948), S3173335 (REBP0949), S3173355 (REBP0950), S9173108PD (REBP1020), s3173355p (REBP1023), S3173335P (REBP1024), S3274108D (REBQ1276), S1173108 (REBQ1882), S1173108 (REBQ2473), S1173108D (REBQ2474), S9173108D (REBQ2475), S1173108PD (REBQ2479), S0173108PD (REBR1399), S1173108PD (REBS0167), S3274108D (REBQ2476), S3173108PD (REBQ2480), S3173355 (REBQ2586), S3173335 (REBQ2587), s3173355p (REBQ2590), s3173108d (REBQ2592), S1173108PD (REBR1398), S0173108PD (REBS2081), S1274108D , REBS0062), S1274108D (REBS1035), S1274108D (REBS1567), S1274108D (REBR1347), S9274108D (REBQ2477), S3274355P (REBS0026), S3274335P (REBS0534), S3274335 (REBS0574), S3274355P (REBS1557), S3274355P (REBS2011), S3274355P (REBS2550), S1274108D (REBS2562), S1274118 (REBT0078), s1274108pd (REBT0146), S1274108PD (REBT0146), S3274355P (REBT0168), S3274355P (REBT0204), CK000765 (REBT0255), S1274108 (REBT0682), S0274108PD (REBT0697), S9274108D (REBT0754), S1274108D (REBT0755), S1274108PD (REBT0757), S3274335 (REBT0805), CK000765 (REBT0843), S9274108PD (REBT1446), S9274108 (REBT1885), CK000767 (REBT1889), S3274108PD (REBT2364), S9274108D (REBU0059), CK000767 (REBW1216), S3274355 (REBR1259), S3173355 (REBR1261), S1274108PD (REBR1345), S3274108PD (REBR1401), S1274108D (REBS0781), S3274355P (REBS0843), S1274108D (REBS1033), S1274108D (REBS2070), CK000759 (REBS2133), S3173355P (REBT0101), S3173335P (REBT0116), S3173355P (REBT0737), S3274335 (REBT1585), S1274108D (REBT1602), S3274355 (REBT1802), S3274108 (REBT1884), ck000770 (REBU0664), S9274108D (REBU0691), S1173108 (REBU1584), S9274108D (REBU1639), S1173108D (REBV0536), S1274108D (REBW0268), S3173108D (REBR1014), S1173108D (REBS1988), S3173108D (REBT0147), S9173108PD (REBT0234), S1173108D (REBT0240), S1173108D (REBT1398), S3173355P (REBT1801), S3173108 (REBT1882), S9173108 (REBT1883), S3173355P (REBT1948), S3173355P (REBU0082), S1173108D (REBU0293), S1173108D (REBU0690), S3173355P (REBU0714), S0173108PD (REBU1224), S3173355P (REBU1265), s9173108pd (REBU2255), S3173335P (REBV0052), S3173118 (REBV1102), S9173118 (REBV1103), S1173108PD (REBW1843), S3173108PD (REBX1664), s1173108 (REBT0688), S1274108D (REBU0296), S1274108D (REBU0765), S1274108 (REBU1047), S1274108D (REBU1271), S9173108D (REBU1640), S1274108PD (REBW0728), s3173355 (REBW1532), S1173108 (REBX1560), S1173108PD (REBX1663), S3173118 (REBY0008), S1173108D (REBY0782), S1173108PD (REBY0832), S0173108PD (REBY1316), S1173108 (REBY1472), S1173108D (REBY2516), CK000283A (REBV1203), S3173108PD (REBS0171), S3274108PD (REBT0233), S9274108PD (REBT1340), S3274108PD (REBT1403), S1274108 (REBT1846), s1274108 (REBT2073), S9274118 (REBU0001), S9274118 (REBU0002), S3274355 (REBU0083), S3274108D (REBU0297), S9274108PD (REBU0694), S3274355 (REBU0734), S3274355 (REBV0533), S3274118 (REBV1104), CK000114A (REBV2151), S1274108PD (REBV2327), S1274108D (REBW1840), S1274108D (REBX0325), CK000770 (REBX0460), S1274108D (REBX1581), CK000759 (REBX2038), S1274108D (REBX2436), S1274108D (REBX0326), S1274108PD (REBY0780), S1274108D (REBY0835), S1274108 (REBY1004), S1274108D (REBZ0814), CK000114A (REBZ1268), S1274108D (REBV1690), CK000770 (REBV2233), S1274108D (REBV2326), S1274108D (REBW0782), CK000759 (REBW1228), S1274108D (REBW1841), S1274108D (REBW1988), CK000767 (REBX0441), CK000759 (REBX0457), S1274108PD (REBX1122), S1274108D (REBX1240), S1274108PD (REBY1239), S1173108D (REBZ0958), S1173108PD (REBZ1627), S1274108D (RECN0085), S1274108PD (RECN0939), S1274108 (RECN1068), CK000114A (RECQ0041), S3173335 (REBY1941), S1173108D (REBY1982), S9173108PD (REBZ0816), S1173108D (REBZ0838), S1173108PD (REBZ0840), S3173108PD (REBZ0960), S1173108PD (RECN0088), S1173108D , RECN1199), s1173108pd (RECN1200), S3173108PD (RECN1406), S1173108D (RECN2175), S1173108PD (RECN2177), S0173108PD (RECN2678), S1173108D (RECP0357), S1173108PD (RECP0594), S1173108 (RECP1895), S3173355 (RECP2311), S1274108D (REBY0518), S3274108D (REBY0834), S1274108PD (REBY2518), S1173108PD (REBY2740), S9274108PD (REBZ0815), s1274108pd (REBZ1718), S1274108PD , RECN0027), S1274108PD (RECN2563), S3274108D (REBX2246), S3274335 (REBY0879), S1274108D (REBY2013), S3274335 (RECN0888), S1274108D (RECN0938), S1274108D (RECN2573), S3274108D (RECN2679), S9274108D (RECP0358), S1274108D (RECP0590), S3274355 (RECP0846), S1274108PD (RECP2482), S3274108D (RECQ0417), S3274108D (REBY2517), S1274108D (REBY2739), S3274355 (REBZ0494), S3274335 (REBZ0681), S3274108D (REBZ0839), S1274108D (REBZ0885), S1274108D (REBZ1625), S1274108 (REBZ1678), S1274108D (RECN1381), S1274108D (RECN2461), S3274108D (RECP0591), S9274108PD (RECP1511), S3274355 (REBZ1826), S3274108D (RECN0023), S9274108D (RECN0084), S9274108D (RECN1403), S1173108 (REBY1170)

510(k) numbers

["K162443"]

PMA numbers

not on file

Product code

LJS

Firm FEI

3006260740

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

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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