Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 85 of 138
Arrow International Inc
Class II Terminated
Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1325-2018 April 18, 2018 Reading, PA
ICU Medical, Inc.
Class II Terminated
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clem...
Reason: The infusion sets were manufactured with an incorrect spin collar.
Z-1347-2018 April 18, 2018 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icume...
Reason: The infusion sets were manufactured with an incorrect spin collar.
Z-1343-2018 April 18, 2018 San Clemente, CA
Arrow International Inc
Class II Terminated
AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-4285...
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1326-2018 April 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CD...
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1335-2018 April 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1323-2018 April 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1334-2018 April 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1327-2018 April 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit ...
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1324-2018 April 18, 2018 Reading, PA
ICU Medical, Inc.
Class II Terminated
7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administratio...
Reason: The infusion sets were manufactured with an incorrect spin collar.
Z-1344-2018 April 18, 2018 San Clemente, CA
Arrow International Inc
Class II Terminated
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Z-1328-2018 April 18, 2018 Reading, PA
C.R. Bard, Inc.
Class II Terminated
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bl...
Reason: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1307-2018 April 11, 2018 Covington, GA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04120
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1284-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04122
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1285-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04220
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1286-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04018
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1281-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arterial Access Tray, introducer catheter; Model: GU-04020
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1287-2018 April 11, 2018 Reading, PA
C.R. Bard, Inc.
Class II Terminated
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Reason: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1308-2018 April 11, 2018 Covington, GA
C.R. Bard, Inc.
Class II Terminated
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52...
Reason: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1309-2018 April 11, 2018 Covington, GA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04020
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1282-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Model: AK-04020-C
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Z-1283-2018 April 11, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Reason: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Z-1194-2018 April 4, 2018 Reading, PA
Cook Vascular Inc.
Class II Terminated
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-t...
Reason: Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-c...
Z-1223-2018 April 4, 2018 Vandergrift, PA
Cook Inc.
Class II Terminated
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended f...
Reason: Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable ga...
Z-1187-2018 April 4, 2018 Bloomington, IN
Medtronic Inc
Class I Terminated
6F Taiga Guiding Catheter
Reason: Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
Z-1207-2018 April 4, 2018 Minneapolis, MN