Recall Z-1682-2010 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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.
| Date | May 26, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |