| | Class 1 Device Recall BD 4 Fr. Single Lumen PowerPICC Catheter |  |
| Date Initiated by Firm | March 11, 2025 |
|---|
| Date Posted | April 16, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1507-2025 |
|---|
| Recall Event ID |
96426 |
| 510(K)Number | K210264 |
|---|
| Product Classification |
Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
|
| Product | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784 |
|---|
| Code Information |
REF/UDI-DI/Lot(Expiration):
3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027);
CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027);
3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026);
CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027);
3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027);
3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027);
CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027);
9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027);
CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025);
3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027);
CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027);
CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027);
3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025);
6174118/00801741139017/REHT2984(1/31/2026);
3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025);
3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025);
2174108/00801741138966/REHU3327(9/30/2025);
9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026);
3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026);
1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025);
CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025);
CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025);
CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026);
1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026);
CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025);
CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025);
9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025);
1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025);
CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025);
3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025);
3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025);
CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025);
1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025);
1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025);
CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025);
CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025);
CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025);
CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025);
CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025);
1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025);
CK000867/00801741163272/REJN2377(5/31/2025);
CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025);
CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025);
CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025);
CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025);
CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025);
CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026);
CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025);
CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025);
CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025);
1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025);
1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025);
1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025);
CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025);
CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025);
CK000411/00801741096303/REJN3872(5/31/2025);
CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025);
1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025);
CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025);
CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025);
CK001021/00801741222863/REJN3927(6/30/2025)
CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025);
CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025);
CK000619A/00801741132001/REJN3985(6/30/2025);
CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025);
3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025);
1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025);
9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025);
CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025);
CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026);
CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025);
CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025);
CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025);
CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025);
CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025);
CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026);
CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025);
CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025);
CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025);
CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025);
CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025);
CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025);
CK000266A/00801741185014/REJP2755(7/31/2025);
1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025);
3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025);
CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027);
1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025);
3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025);
CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025);
1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025);
CK000736/00801741139499/REJQ1480(6/30/2025);
CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026);
9194108/00801741028595/REJR0580(9/30/2025);
1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025);
CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025);
CK000609A/00801741222504/REJR1654(6/30/2025);
9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025);
CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025);
CK000077D/00801741139598/REJR2231(9/30/2025);
CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025);
CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025);
CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025);
CK000870A/00801741184246/REJS3569(10/31/2025);
CK000443C/00801741226557/REJT0880(10/31/2025);
CK000668B/00801741228674/REJT1820(10/31/2025);
CK000784/00801741189012/REJU0379(9/30/2025)
|
| FEI Number |
3006260740
|
Recalling Firm/
Manufacturer |
Bard Access Systems, Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
|
| For Additional Information Contact |
801-522-5000 |
|---|
Manufacturer Reason
for Recall | Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | On 3/11/2025, recall notices were distributed to customers and distributors who were asked to do the following:
Actions if catheter damage is suspected:
1. Stop any infusion if catheter damage is suspected.
2. Follow your institution's guidelines for catheters with suspected damage.
3. If catheter fracture is confirmed, catheter should be removed and an alternative route for access should be obtained.
4. Report any catheter replacements due to leakage to firm's Complaint Center.
Please Take the Following Actions:
1. Destroy all unused product following your institution's process for destruction.
2. If affected device was previously used on a patient without incident, no further action is necessary.
3. Recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
4. Complete and return Customer Response Form via email to Email: BDRC44@BD.com
Distributors asked to identify all customers within distribution network that purchased any affected product. Provide a copy of the attached customer letter to all customers to advise them of this recall
Actions Taken by Firm:
2. Firm is notifying users that adhesive-backed securement systems are recommended.
3. Firm is notifying users that if they do use compression-style securement systems, they must be sized appropriately to accommodate the taper region.
4. Firm has been updating the product IFU with cautions related to the use of compression-style securement systems around the taper region of the PICC.
5. Firm is notifying customers to insert the catheter as close as possible to the zero mark per the IFU.
For further assistance, contact: North American Regional Complaint Center: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT or productcomplaints@bd.com.
On 5/15/2025 additional recall notices were distributed to customers informing them of additional affected devices. |
|---|
| Quantity in Commerce | 718,461 |
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| Distribution | Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LJS
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