Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebrea
FDA device recall Z-0769-05 · posted 2005-04-27 · Terminated
Recall details
- Recalling firm
- Medline Industries, Inc.
- Reason for recall
- The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 116 kits
- Distribution
- California, Alabama, Minnesota, Florida and Indiana.
- Date initiated
- 2005-03-18
- Date posted
- 2005-04-27
- Date terminated
- 2005-10-17
- Location
- Waukegan, IL
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