FDA Medical Device Recalls (openFDA)
Medical Action Industries Inc: Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
- Recall number
- Z-1073-2010
- Recalling firm
- Medical Action Industries Inc
- Product
- Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2010-03-30
- Terminated
- 2011-06-01
- Reason
- Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Root cause
- Nonconforming Material/Component
- Action
- On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
- Quantity
- 12,000 kits
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Part number: 69946B, Lot numbers: 62295, 63591, 64197, 65175, 67162, 69906, 72113 and 73617.
- 510(k) numbers
- ["K013621"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- 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