—#150739

Product

Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K955839
Affected lot / code info: Centurion Kit Code ECVC1680 Kit Description SINGLE LUMEN INSERTION BUNDLE Lot Number(s) 2016062150 2016062950 2016070650 Centurion Kit Code ECVC4785 Kit Description SINGLE LUMEN BUNDLE Lot Number(s) 2016081550 Centurion Kit Code M11620HKIC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016051050 2016053150 2016060750 2016061550 2016063050 2016072050 2016080250 2016091950 Centurion Kit Code M11620HKICNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060750 2016072650 2016093050 2016101050 Centurion Kit Code M11620HS Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016052050 2016062850 2016082350 2016082650 2016090250 Centurion Kit Code M11620KC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016050950 2016053150 2016060750 2016071250 2016080350 2016082950 Centurion Kit Code M11620KCNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060850 2016061650 2016062050 2016070550 2016071950 2016080250 2016090750 Centurion Kit Code M12013K Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016071350 2016072050 2016092650 2016100650 Centurion Kit Code M12013KNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016072950 2016082450

Why it was recalled

The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.

Root cause (FDA determination)

Process control

Action the firm took

Centurion sent an Urgent Recall Notice dated October 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356. For questions regarding this recall call 517-546-5400.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-10-21
Posted by FDA: 2016-12-02
Terminated: 2017-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.