PowerPICC Provena Catheters recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

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.

Recalling firm

Bard Access Systems Inc.

Quantity

53,699 units total

Distribution

Distribution US nationwide.

Recall date

February 14, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)