FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD: Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
- Recall number
- Z-0936-03
- Recalling firm
- Abbott Laboratories HPD/ADD
- Product
- Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
- Status
- Terminated
- Initiated
- 2003-05-13
- Posted
- 2003-06-17
- Terminated
- 2003-11-20
- Reason
- The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
- Root cause
- Other
- Action
- Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
- Quantity
- 4,656 units
- Distribution
- Miami, FL
- Lot, serial or model codes
- List number 19020-04-12, lot 941845H
- 510(k) numbers
- ["K791930","K832755","K865060","K941214"]
- PMA numbers
- not on file
- Product code
- FPA
- 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