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Terminated

Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).

FDA Recall Z-0256-04 · Posted 2004-07-20

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2003-11-04
Date Terminated2004-11-12
Product Quantity913

Reason for Recall

The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

Firm Action

The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall').

Root Cause

Other

Distribution Pattern

Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960200INTROSTAT LEAD INTRODUCERMsi, Inc. · 1996-07-02K934802THEREX LOW-PROFILE PORT-TITANIUMTherex Corp. · 1994-03-22K933316THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEMTherex Corp. · 1994-02-23K921475A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CMTherex Corp. · 1992-10-16

Official Source

View FDA Recall →

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

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