FDA Medical Device Recalls (openFDA)
Covidien LLC: Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
- Recall number
- Z-0756-2017
- Recalling firm
- Covidien LLC
- Product
- Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
- Status
- Terminated
- Initiated
- 2016-10-14
- Posted
- not on file
- Terminated
- 2018-08-08
- Reason
- Sterility of the outer surface of the container compromised due to packaging defect.
- Root cause
- Packaging process control
- Action
- Covidien initiated recall by letter on October 14, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Accounts requested to completed Recalled Product Return From to obtain an RGA. Questions: Contact your Medtronic representative or Customer Service at (800) 882-5878.
- Quantity
- 5,187,100 Units
- Distribution
- Nationwide Foreign: Japan
- Lot, serial or model codes
- All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMH
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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