FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia mask, suction tubing, humid vent hme filter and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
- Recall number
- Z-0771-05
- Recalling firm
- Medline Industries, Inc.
- Product
- Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia mask, suction tubing, humid vent hme filter and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
- Status
- Terminated
- Initiated
- 2005-03-18
- Posted
- 2005-04-27
- Terminated
- 2005-10-17
- Reason
- The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.
- Root cause
- Other
- Action
- Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline.
- Quantity
- 8,500 kits
- Distribution
- California, Alabama, Minnesota, Florida and Indiana.
- Lot, serial or model codes
- reorder number DYNJAA0078C, lots 04KD3355, 04KD4186, 04KD4500, 04LD1866, 04LD2479, 04LD3673, 05AD3501, 05BD0357, 05BD4129
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- 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