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Terminated

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.

FDA Recall Z-1682-2010 · Posted 2010-05-26

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2010-03-29
Date Terminated2012-09-27
Product Quantity6719

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073451PRESSURE INJECTABLE PICCArrow International, Inc. · 2008-01-15K061289ARROW PRESSURE INJECTABLE PICCArrow International, Inc. · 2006-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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