The Recall Desk
ModerateFDA (Devices)·Z-0622-2018·Announced 2018-02-21

Medtronic Recalls Clip Gun Scalp Clip Kits Due to Packaging Defects

Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a voluntary precautionary action for packaging performance issues without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Medtronic Neurosurgery is initiating a voluntary recall of Model CG8900, CG8901, and CG8901A Clip Gun Scalp Clip Kits and Applicators. The recall involves 27,432.8 devices distributed across 33 countries and territories, including the United States, Canada, and various locations in Europe, Asia, and the Middle East.

The recall was initiated because the identified products did not adequately demonstrate acceptable packaging performance to current standards. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the official recall notice. If affected products are found, they should be removed from use and returned to Medtronic Neurosurgery according to their instructions.

The recalled product

Product
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

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 (20)

  • Affected Lots: D80412
  • D84100
  • E00008
  • E00983
  • E03049
  • E03716
  • E05806
  • E07257
  • E09145
  • E14782
  • E14896
  • E15195
  • E19181
  • E19182
  • E19183
  • E19184
  • E19868
  • E20599
  • E23631
  • E33102

Distribution

Distributed in 1 state: