Z-0782-2018Class II

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

Name: Z-0782-2018 AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Creator: Avid Medical, Inc.
Published: 2017-06-22
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2017-06-22 / Terminated / root cause: manufacturing process

FDA source

Avid Medical, Inc. began a recall of AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04 on 2017-06-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0782-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Posted: 2018-02-28
Terminated: 2018-10-12
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to [email protected] that your customers were notified.
Quantity in commerce: 48
Distribution: Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Product codes and lots: Lot, Expiration Date: 1203562, 12/1/2017; 1206458, 1/1/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0782-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0781-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0782-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0783-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0784-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0785-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0786-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0787-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0788-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0789-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0790-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0791-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0792-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0793-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0794-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0795-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0796-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0797-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0798-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0799-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0800-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0801-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28
Z-0802-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)