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Medical Device Safety Alert: Medline ACME Monaco Guidewire

Model Catalog: DYNJ33248X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46912X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41909X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41699X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48535X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41790X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48528X (Lot serial: CONTACT MFG); Model Catalog: DYNJ50501X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41704X (Lot serial: CONTACT MFG); Model Catalog: DYNJ54021X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41799X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41694X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41712X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900657X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900656X (Lot serial: CONTACT MFG); Model Catalog: DYNJ51582X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41914X (Lot serial: CONTACT MFG); Model Catalog: DYNJ51653X (Lot serial: CONTACT MFG)

ANGIO RADIOGRAPH;HEART BIOPSY PACK TWH-LF;HAND FINGERS PACK LF;LAPAROSCOPIC CHOLE PACK;VAGINAL HYSTERECTOMY MSH-LF;GYNE MINOR LAPAROSCOPY GRH LF;LAVH MSH-LF;PLASTIC IMPLANT PACK HSN;PACEMAKER PACK LF;BREAST PACK;GENERAL MINOR ABDOMINAL GRH LF;VAG RECTAL P

SKU Nos.: P1001, P-1011, P-1001-8S, P-1011-8S Multiple lot numbers of the affected device are provided in the attached file.

Procedure Kit/Trays

Model Catalog: DYNJ21718 (Lot serial: ); Model Catalog: DYNJ21721 (Lot serial: ); Model Catalog: DYNJ21722 (Lot serial: )

Total Hip Pack

Surgical equipment/ Anaesthesia - surgical equipment

IV4285  Lot codes: 2016032890 2016091290 2016112890

General and Plastic Surgery Devices

1

No

Nationally

BLOOD DRAW KIT

Medline Industries: Bocal d'aspiration MED-RIGID 2L

Model Catalog: 514497 (Lot serial: 96047848); Model Catalog: 514497 (Lot serial: 99061657.); Model Catalog: 514497NH (Lot serial: 99020276 98037428); Model Catalog: 514497 (Lot serial: 99020276 98037428); Model Catalog: 514491NH (Lot serial: 99020276 98037428); Model Catalog: 514497NH (Lot serial: 99117575 99127103); Model Catalog: 514497 (Lot serial: 99117575 99127103); Model Catalog: 514491NH (Lot serial: 99117575 99127103); Model Catalog: 514497NH (Lot serial: 99061657.); Model Catalog: 514497NH (Lot serial: 96047848); Model Catalog: 514491NH (Lot serial: 96053387 96024838); Model Catalog: 514497 (Lot serial: 96053387 96024838); Model Catalog: 514497NH (Lot serial: 96053387 96024838); Model Catalog: 514491NH (Lot serial: 99061657.); Model Catalog: 514491NH (Lot serial: 96047848)

BOVIE ELECTROSURGICAL PENCIL

Model Catalog: DYNJ31903X (Lot serial: 09JD1513); Model Catalog: DYNJ31903X (Lot serial: 09FD3115); Model Catalog: DYNJ31903X (Lot serial: 09FD0041); Model Catalog: DYNJ31903X (Lot serial: 09ED3002); Model Catalog: DYNJ31903X (Lot serial: 09ED0655); Model Catalog: DYNJ31903X (Lot serial: 09CD3097); Model Catalog: DYNJ31903X (Lot serial: 09LD0272); Model Catalog: DYNJ31903X (Lot serial: 09LD2807); Model Catalog: DYNJ31903X (Lot serial: 10AD0647); Model Catalog: DYNJ31903X (Lot serial: 09KD1837); Model Catalog: DYNJ31903X (Lot serial: 10AD3494)

CARDIAC PROCEDURE PACK

CSS490  Lot codes: 2016022290 2017071790

General and Plastic Surgery Devices

1

No

Nationally

CATHETER SECUREMENT SYSTEM

Cautery Pen Push Button PTFE Coated bladeProduct Code: ESPB3002Lot Number: JS-2012-A006-1ARTG Number: 200330

Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.   Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015  Serial No: N/A UPC code: N/A

Cardiovascular Devices

2

No

US including PA

Central Line >34 Weeks Kit. Cardiology department. || The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

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

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

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.

CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03

Cardiovascular Devices

1

No

Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

CMP Kit code: MNS2955 Lot numbers: 2014061250 Expiration date: 2015-11

General and Plastic Surgery Devices

2

No

Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Diagnostic Imaging Tray (General Surgery convenience kit)

CMP Kit code: DT13405 Lot numbers: 2014061250 and 2014071750 Expiration date lot 2014061250: 2016-02  Expiration date lot 2014071750: 2016-03

Anesthesiology Devices

2

No

Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Nerve Block Tray (Nerve Block convenience kit)

2009100590, 2009110990, 2009121490, 2010011190 and 2010031590.

General and Plastic Surgery Devices

2

No

TX

Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.

CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03

Cardiovascular Devices

1

No

Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)