Z-0647-2017Class I

Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for...

Name: Z-0647-2017 Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for...
Creator: Centurion Medical Products Corporation
Published: 2016-10-21
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2016-10-21 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of... on 2016-10-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0647-2017
Classification: Class I
Status: Terminated
Initiated: 2016-10-21
Posted: 2016-12-02
Terminated: 2017-07-20
Recalling firm: Centurion Medical Products, LP
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1000 kits
Distribution: Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0647-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0647-2017	Class I	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-02

Product code FOZ

K955839Class IIMulti-Med Multi-Lumen Central Venous CatheterBaxter Edwards / cleared 1996-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)