Class 2 Device Recall PowerPICC catheter

• Date Initiated by Firm: December 28, 2017
• Date Posted: February 06, 2018
• Recall Status: Terminated on June 14, 2021
• Recall Number: Z-0536-2018
• Recall Event ID: 79070
• 510(K)Number: K162443
• Product Classification: peripherally inserted central catheter - Product Code LJS
• 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.
• Code Information: 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)
• Recalling Firm/ Manufacturer: Bard Access Systems Inc.; 605 N 5600 W; Salt Lake City UT 84116-3738
• Manufacturer Reason for Recall: Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
• FDA Determined 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 in Commerce: 53,699 units total
• Distribution: Distribution US nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJS