—#26181

Product

Custom Angiographic Kit

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K883718, K913682, K934123, K973230
Affected lot / code info: Model Number: K08-MP5130. Lot Numbers: A146066, A188604.

Why it was recalled

A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by phone and FAX on 2/12/2003.

Recalling firm

Firm: Merit Medical Systems, Inc
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern: FL and Japan.

Timeline

Recall initiated: 2003-02-13
Posted by FDA: 2003-03-06
Terminated: 2003-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.