FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD: LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289
- Recall number
- Z-0915-03
- Recalling firm
- Abbott Laboratories HPD/ADD
- Product
- LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289
- Status
- Terminated
- Initiated
- 2003-05-13
- Posted
- 2003-06-05
- Terminated
- 2003-11-20
- Reason
- IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
- Root cause
- Other
- Action
- Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit.
- Quantity
- 5,680 units
- Distribution
- Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin.
- Lot, serial or model codes
- product number 19289-04-02, lot 960445H
- 510(k) numbers
- ["K832755"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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