Class I - Dangerous
Potential for stylet to protrude from the distal end of the catheter
Epimed International
Class I - Dangerous
Potential for stylet to protrude from the distal end of the catheter
Class I - Dangerous
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Incorrect expiration date on introduction cannula packaging.
Incorrect expiration date on introduction cannula packaging.
Class I - Dangerous
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Class I - Dangerous
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Class I - Dangerous
Potential for partially incomplete seal of product, impacting sterility.
Class I - Dangerous
Potential for partially incomplete seal of product, impacting sterility.
Class I - Dangerous
Potential for partially incomplete seal of product, impacting sterility.
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.