MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device i...
Reason: There is potential for nonsterility of product due to a possible defect in the pouch seal.
Z-2441-2021September 15, 2021Eden Prairie, MN
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2371-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2359-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2372-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2362-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2374-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2361-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2360-2021September 8, 2021North Haven, CT
Magnolia Medical Technologies, Inc.
Class IITerminated
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Col...
Reason: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2363-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2375-2021September 8, 2021North Haven, CT
Covidien, LP
Class IIOngoing
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Z-2358-2021September 8, 2021North Haven, CT
W. L. Gore & Associates Inc.
Class IIOngoing
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Reason: Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to infl...
Z-2340-2021September 1, 2021Phoenix, AZ
Northeast Scientific Inc.
Class IITerminated
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such v...
Reason: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Z-2334-2021September 1, 2021Waterbury, CT
Delta Med SpA
Class IIOngoing
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2296-2021August 25, 2021Viadana, N/A
Delta Med SpA
Class IIOngoing
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Reason: Potential for leaks and loosening at the patient catheter connection
Z-2328-2021August 25, 2021Maple Grove, MN
Delta Med SpA
Class IIOngoing
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2301-2021August 25, 2021Viadana, N/A
Delta Med SpA
Class IIOngoing
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2298-2021August 25, 2021Viadana, N/A
Delta Med SpA
Class IIOngoing
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2304-2021August 25, 2021Viadana, N/A
Cardinal Health 200, LLC
Class ITerminated
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Pr...
Reason: The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not a...
Z-2244-2021August 25, 2021Mansfield, MA
Delta Med SpA
Class IIOngoing
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Reason: Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complicat...