Recall Z-0865-2020— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2020-01-07, terminated 2020-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico. Reason: There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-07
- Terminated
- 2020-09-16
- Firm location
- Northfield, IL, United States
Product description
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico
Reason for recall
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.