Medtronic—Clip Gun Magazines: Sterility May Be Compromised
May 9, 2018 | Risk Management News
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In a May 3, 2018, Urgent Medical Device Recall letter, Medtronic states that the above products may not meet the requirement of post-sterile seal integrity. Medtronic's testing showed that the packaging sterile barrier of the above devices does not comply with the applicable packaging standard for terminally sterilized medical devices, and that the devices do not meet the requirement of post-sterile seal integrity as outlined in ISO-11607. Medtronic further states that while the instructions for use (IFU) state "Do not use if package has been previously opened or damaged," a user may be unable to detect the seal breach. Medtronic also states that it has received no reports related to...