Z-1682-2010

Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC...

Name: Z-1682-2010 Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC...
Creator: Arrow International Inc
Published: 2010-03-29
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-03-29 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of 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... on 2010-03-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1682-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-05-26
Terminated: 2012-09-27
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 6719
Distribution: Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.
Product codes and lots: 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.

Product code LJS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)