—#160975

Product

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K121941
Affected lot / code info: Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.

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 #160975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.