—#160976

Product

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K113277
Affected lot / code info: Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.

Why it was recalled

Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Root cause (FDA determination)

Packaging process control

Action the firm took

Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2017-07-25
Terminated: 2018-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160976. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.