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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 59 of 1581

Evidence Product Join Root cause
device-recall:cfres:175769 Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958 Official recall number · Z-0261-2020 Nonconforming Material/Component
device-recall:cfres:176888 Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians Official recall number · Z-0237-2020 No Marketing Application
device-recall:cfres:176681 The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372. Official recall number · Z-0258-2020 Software design
device-recall:cfres:177005 Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel. Official recall number · Z-0215-2020 Nonconforming Material/Component
device-recall:cfres:176788 A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum. Official recall number · Z-0245-2020 Process control
device-recall:cfres:167467 Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures. Official recall number · Z-0228-2020 Employee error
device-recall:cfres:176463 Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser. Official recall number · Z-0208-2020 Other
device-recall:cfres:174213 Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap Official recall number · Z-0180-2020 Packaging
device-recall:cfres:176346 Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9 Official recall number · Z-0185-2020 Software design
device-recall:cfres:175289 Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied. Official recall number · Z-0192-2020 Packaging process control
device-recall:cfres:174217 Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap Official recall number · Z-0184-2020 Packaging
device-recall:cfres:172934 SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use Official recall number · Z-2614-2019 Component design/selection
device-recall:cfres:173578 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use Official recall number · Z-2655-2019 Component design/selection
device-recall:cfres:172088 SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use Official recall number · Z-2595-2019 Component design/selection
device-recall:cfres:173672 SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardiovascular use Official recall number · Z-2716-2019 Component design/selection
device-recall:cfres:171760 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use Official recall number · Z-2563-2019 Component design/selection
device-recall:cfres:173657 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use Official recall number · Z-2701-2019 Component design/selection
device-recall:cfres:173619 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for cardiovascular use Official recall number · Z-2675-2019 Component design/selection
device-recall:cfres:173511 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use Official recall number · Z-2627-2019 Component design/selection
device-recall:cfres:172933 SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use Official recall number · Z-2613-2019 Component design/selection
device-recall:cfres:176398 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. Official recall number · Z-0002-2020 Process control
device-recall:cfres:173686 SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use Official recall number · Z-2728-2019 Component design/selection
device-recall:cfres:173594 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use Official recall number · Z-2665-2019 Component design/selection
device-recall:cfres:173643 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascular use Official recall number · Z-2689-2019 Component design/selection
device-recall:cfres:173613 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use Official recall number · Z-2669-2019 Component design/selection

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