Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in surgical procedures. Unapproved design changes to surgical instruments represent a significant risk of harm in a healthcare setting, meeting the Severe classification criterion.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The affected kits include bariatric, gynecology laparotomy, laparoscopy, major plus, minimally invasive, percutaneous, and robotic surgical packs distributed nationwide across the United States and Barbados.
The manufacturer identified unapproved design changes to these products that fall outside of the FDA 510(k) clearance. The products were not initially reported in FDA recall number RES 98601.
Approximately 113,843 kits have been distributed. A comprehensive list of affected product codes and lot numbers is available from the FDA, and healthcare facilities that received these kits should verify the UDI-DI numbers and lot codes against the FDA's official recall notice.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- regulatory-noncompliance
Distribution
Distributed nationwide across the United States.
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