Centurion Medical Products Corporation: 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.

Recall number

Z-0647-2017

Recalling firm

Centurion Medical Products Corporation

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.

Status

Terminated

Initiated

2016-10-21

Posted

2016-12-02

Terminated

2017-07-20

Reason

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

Process control

Action

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.

Quantity

1000 kits

Distribution

Nationwide Distribution

Lot, serial or model codes

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

510(k) numbers

["K955839"]

PMA numbers

not on file

Product code

FOZ

Firm FEI

3008403546

Firm city

Williamston

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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