FDA Enforcement
Class II
Terminated
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure.
Recall: Z-0568-2013
·
Reported December 26, 2012
Enforcement
- Recall Number
- Z-0568-2013
- Event ID
- 63739
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 26, 2012
- Initiation Date
- November 8, 2012
- Classification Date
- December 19, 2012
- Termination Date
- December 20, 2012
- Address
- 1 Medline Pl, Mundelein, IL, 60060, United States
Description
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure.
Reason
The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
Code Info
Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
Distribution
Nationwide distribution: New York only.
Quantity
105 packs