Reported Oct 21, 2015 · Terminated

4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

Arrow International Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607

Is this the product you have?

- 4FR Single Lumen Pressure Injectable PICC
- intravascular therapeutic catheter
- for long-term use greater than 30 days

Lot codes and dates: Material Numbers
ASK-05041-CHC2
ASK-05041-LM4
ASK-05041-QV
ASK-05541-MS3
CA-05041-HP
CA-05041-HPX
CDC-04041-HPK1A
CH-04041-HMA
EU-04041-HP
EU-05041-HPMSB
EU-05541-HP
EU-05541-HPMSB
EU-24041-HP
EU-24041-HPMSB
EU-24041-IR
EU-25041-HP
EU-25041-HPMSB
EU-25041-IR
EU-25541-HP
EU-25541-HPMSB
EU-25541-IR
FR-04041
FR-04041-CF
FR-05041
FR-05041-CF
PR-04041-HPX
PR-05041-HP
PR-05541-HPX
UK-04041-RDE1
UK-04041-THT
UK-05041-HPMIN
UK-05041-MSB
UK-05041-RDE1
UK-05041-THT
with Batch Nos.
269 of 269 codes
23F15E0620
23F15A0584
23F14H0964
23F14F1422
23F13J0289
23F13H0832
23F15C2435
23F14L0090
23F14H0848
23F14F0370
23F14A1352
23F13K0761
23F14H0193
23F15C1236
23F14M0484
23F14L0810
23F14K1361
23F14J0415
23F14E1093
23F14B0844
23F15D0881
23F14L0187
23F15F0752
23F15A1857
23F15D0830
23F14H1112
23F14F1497
23F14C1096
23F14C0640
23F14A1238
23F14A1419
23F14L1144
23F14J1513
23F15D0832
23F15F0147
23F15C0303
23F14J0221
23F14F1504
23F14C0643
23F13K0097
23F13H0994
23F13H0013
23F15F0151
23F15C1553
23F15B0400
23F14K1025
23F14H0328
23F14F1505
23F14C0598
23F13K0003
71F14L0736
71F14K1846
71F15B1940
71F13M1092
71F13L0510
71F14A1536
71F14C0247
71F14B1735
71F14F1289
71F14E2029
Amount recalled: 31590

Where it was sold

Nationwide

Why it was recalled

Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.

This product could cause temporary or reversible health problems — stop using it.

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