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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Avid Medical, Inc.: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Agency Publication Date: February 28, 2018
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Affected Products

Product: AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09

Lot, Expiration Date: 1205900, 1/1/2019; 1214034, 2/1/2019

Product: AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12

Lot, Expiration Date: 1205011 8/1/2019 1213805 10/1/2019

Product: AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04

Lot, Expiration Date: 1203562, 12/1/2017; 1206458, 1/1/2018

Product: AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09

Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019

Product: AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Lot, Expiration Date: 1193636 ,1/1/2019; 1198134, 10/1/2019

Product: AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08

Lot, Expiration Date: 1194408, 10/1/2018; 1204116, 10/1/2018; 1216669, 12/1/2018; 1216670, 11/1/2018

Product: AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14

Lot, Expiration Date: 1190449, 2/1/2019; 1210124, 6/1/2019; 1217082, 8/1/2019; 1219275, 3/1/2019; 1221265, 3/31/2019; 1222551, 7/1/2019

Product: AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04

Lot, Expiration Date: 1150308 ,1/1/2020

Product: AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02

Lot, Expiration Date: 1212610, 12/1/2017; 1218388, 8/1/2019

Product: AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08

Lot, Expiration Date: 1213947, 7/1/2019; 1216720, 10/1/2018; 1221271, 8/1/2017

Product: AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

Lot, Expiration Date: 1191787, 7/1/2018; 1216674, 9/1/2019

Product: AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02

Lot, Expiration Date: 1197468, 8/1/2019; 1197469, 8/1/2019

Product: AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02

Lot, Expiration Date: 1197473, 6/1/2018; 1213733, 6/1/2018

Product: AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04

Lot, Expiration Date: 1207468, 9/1/2019; 1216677, 9/1/2019; 1221264, 9/20/2019; 1222553, 9/1/2019

Product: AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01

Lot, Expiration Date: 1210946, 8/1/2018; 1211091, 10/1/2018; 1213010, 8/1/2018

Product: AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08

Lot, Expiration Date: 1212598, 12/31/2018

Product: AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06

Lot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018

Product: AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016

Lot, Expiration Date: 1211878, 7/1/2018

Product: AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03

Lot, Expiration Date: 1203380 ,8/1/2018; 1203381, 8/1/2018; 1203382, 12/1/2018; 1211709, 12/23/2018

Product: AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03

Lot, Expiration Date: 1203390, 9/1/2019; 1203391, 12/1/2017; 1218389, 10/1/2019; 1218390, 10/1/2019

Product: AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02

Lot, Expiration Date: 1203383, 9/1/2018; 1217833, 12/31/2018; 1218421, 12/1/2018

Product: AVID TruCustom SPINE convenience kits, Item Code: LITT016-04

Lot, Expiration Date: 1211095, 3/1/2018; 1216086, 3/1/2018

Product: AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04

Lot, Expiration Date: 1189012 , 7/1/2019; 1213716, 9/1/2019; 1216726, 10/1/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79162
Status: Resolved
Manufacturer: Avid Medical, Inc.
Manufactured In: United States
Units Affected: 23 products (50; 200; 48; 70; 354; 597; 444; 15; 48; 630; 160; 24; 12; 120; 44; 46; 90; 8; 440; 52; 24; 30; 216)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.