FDA Medical Device Recalls (openFDA)
Avid Medical, Inc.: AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
- Recall number
- Z-0782-2018
- Recalling firm
- Avid Medical, Inc.
- Product
- AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
- Status
- Terminated
- Initiated
- 2017-06-22
- Posted
- not on file
- Terminated
- 2018-10-12
- Reason
- 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
- 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 QualityAssurance@owens-minor.com that your customers were notified.
- Quantity
- 48
- Distribution
- Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
- Lot, serial or model codes
- Lot, Expiration Date: 1203562, 12/1/2017; 1206458, 1/1/2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28