Laparoscopy and cysto kits recalled over cracked anesthesia circuit tubing
Medline is recalling robotic gastric sleeve, cysto and general laparoscopy kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
Medline convenience kits DYNJ909119G (ROBOTIC GASTRIC LAP SLEEVE-LF), DYNJ909127F (CYSTO) and DYNJ909129D (GENERAL LAPAROSCOPY-LF) are being recalled.
The firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120 inch expandable tubing. Medline states that cracks and resulting leaks may lead to hypoxia, hypoventilation and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death, and that volatile anesthetics may also escape into the operating room environment.
The action covers 96,406 total units across the affected kits. The CYSTO kit carries case UDI-DI 40198459055424 and each UDI-DI 10198459055423, lots 25FBP819 and 25GBM605. Distribution was nationwide in the United States and internationally to Mexico and Panama. The FDA has classified the recall as Class I, its most serious category.
Facilities should quarantine affected lots immediately and follow Medline's instructions.
The recalled product
- Product
- DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 96,406
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- CYSTO DYNJ909127F UDI-DI 40198459055424 (case)
- 10198459055423 (ea) Lots 25FBP819 25GBM605
- GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case)
- 10198459055263 (ea) Lots 25FBV537
- ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case)
- 10198459130526 (ea) Lots 25FBP681
Distribution
Part of a larger recall action
This product is one of 10 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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