Arrow International Inc: Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

Recall number

Z-1682-2010

Recalling firm

Arrow International Inc

Product

Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

Status

Terminated

Initiated

2010-03-29

Posted

2010-05-26

Terminated

2012-09-27

Reason

Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a

Root cause

Nonconforming Material/Component

Action

Arrow International issued an Urgent Medical Device Recall letter dated 3/29/10 to inform their customers of the problem and the need to return the product.

Quantity

6719

Distribution

Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.

Lot, serial or model codes

Product number ASK-01451-BMH - Lot numbers RF8060214 and RF8096394; Product number ASK-05041-CHC - Lot numbers RF8109279 and RF9056727; Product number ASK-05041-CHC1 - Lot numbers RF9069677 and RF9098408; Product number ASK-05041-CHM - Lot numbers RF8057827 and RF8068899; Product number ASK-05041-HMC - Lot numbers RF8068662, RF8083994, RF8108545, RF9043625, RF9056403, RF9085278, and RF9098580; Product number ASK-05041-QV - Lot number RF9097395; Product number ASK-07041-BMH - Lot numbers RF9031839, RF9098784, and RL8108648; Product number CN-05041-LW - Lot numbers RF8069608, RF9056127, RF9070920, and RL9019402; Product number MSO-01451-UCL - Lot numbers RF9057410, RF9084460, RL8118758, and RL9029477; Product number MTO-01451-RH - Lot number RL9019228; Product number PL-05041 - Lot numbers RF8071766 and RF9109677; Product number PR-04041-HPX - Lot numbers RF8072920 and RF8109646; Product number PR-05041 - Lot numbers RF8056742, RF8068423, RF8069651, RF8071677, RF8095208, RF8095832, RF8108465, RF9028902, RF9043449, RF9056132, RF9085152, and RF9086357; Product number PR-05041-HP - Lot numbers RF8072840, RF8083506, RF8084926, and RF8107907; Product number PR-05041-HPX - Lot numbers RF8071099, RF8072981, RF9015967, RF9057607, and RF9097057; Product number PR-05041-LW - Lot numbers RF8057252, RF8072743, RF8083529, RF8108466, RF8110585, RF9031472, RF9044054, RF9060502, and RF9097058; Product number PR-05041-MW - Lot numbers 8057253, RF8060216, RF8095834, RF8108467, RF8110586, RF9016412, RF9031473, RF9044055, RF9069045, RF9071244, RF9085152, RF9086354, RF9100412, and RF9109679; Product number PR-05041-T - Lot numbers RF8068845 and RF8107962; Product number PR-05042 - Lot numbers RF8068846, RF8107963, RF8122680, RF9016413, RF9044057, and RF9073297; Product number PR-05541-HPX - Lot number RF8124014; Product number PR-07041-PTSP - Lot numbers RF8068850, RF8071679, RF8107965, RF8110358, RF9042708, and RF9072922; and Product number RJ-01451-W - Lot numbers RF8068664, RF8096774, RF8123596, and RF9060298.

510(k) numbers

["K061289","K073451"]

PMA numbers

not on file

Product code

LJS

Firm FEI

3015859709

Firm city

Reading

Firm state

PA

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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