APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets an...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0272-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0250-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intravascular Administr...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0245-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)250101(30)50(10)4573963;...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0241-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874; (01)10840619092754(17)250101...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0269-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accesso...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0266-2021October 28, 2020San Clemente, CA
ICU Medical, Inc.
Class IITerminated
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)...
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoC...
Z-0236-2021October 28, 2020San Clemente, CA
Cook Inc.
Class IITerminated
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) ...
Reason: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of ...
Z-0105-2021October 21, 2020Bloomington, IN
Cook Inc.
Class IITerminated
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull ti...
Reason: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of ...
Z-0106-2021October 21, 2020Bloomington, IN
Medline Industries Inc
Class IITerminated
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use ...
Reason: There have been reports of the suction catheter coming apart from the device assembly during use.
Z-0058-2021October 14, 2020Northfield, IL
Bard Peripheral Vascular Inc
Class IITerminated
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal...
Reason: Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that h...
Reason: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Z-0090-2021October 14, 2020Issaquah, WA
ev3 Inc.
Class IITerminated
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Reason: Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Z-3055-2020October 7, 2020Plymouth, MN
Irvine Biomedical Inc, a St. Jude Medical Co.
Class IITerminated
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and card...
Reason: Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 ...
Z-3012-2020September 30, 2020Irvine, CA
Irvine Biomedical Inc, a St. Jude Medical Co.
Class IITerminated
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and card...
Reason: Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 ...
Z-3011-2020September 30, 2020Irvine, CA
Intuitive Surgical, Inc.
Class IIOngoing
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Reason: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can resul...
Z-2950-2020September 16, 2020Sunnyvale, CA
Intuitive Surgical, Inc.
Class IIOngoing
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Reason: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can resul...
Z-2949-2020September 16, 2020Sunnyvale, CA
Medical Components, Inc dba MedComp
Class IITerminated
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Reason: Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
Z-2940-2020September 16, 2020Harleysville, PA
TELEFLEX MEDICAL INC
Class IITerminated
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is...
Reason: Potential sterility issue
Z-2922-2020September 9, 2020Morrisville, NC
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac...
Reason: The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pi...
Z-2921-2020September 9, 2020Malvern, PA
Datascope Corporation
Class IIOngoing
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surger...