FDA Medical Device Recalls (openFDA)
Thermo Fisher Scientific (Monterrey): Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
- Recall number
- Z-0273-2020
- Recalling firm
- Thermo Fisher Scientific (Monterrey)
- Product
- Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
- Status
- Terminated
- Initiated
- 2019-07-18
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
- Root cause
- Equipment maintenance
- Action
- 1. Please notify to any organizations that have received affected product. 2. If you have any affected product please contact Technical Support Team regarding free-of-charge product replacement. Technical Support: Phone - +1-800-625-4327 Email - technicalsupport@thermofisher.com
- Quantity
- 514,200 each
- Distribution
- OH
- Lot, serial or model codes
- Lot # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMH
- Firm FEI
- 3007730738
- Firm city
- Apodaca
- Firm state
- Nuevo Leon
- Firm country
- Mexico
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