Class I Correction for Medical Action Industries Epidural Kits Containing Recalled Ampules
The US FDA has classed a correction of certain Medical Action Industries epidural kits as the most serious type of recall. The kits contain Spectra Medical Devices ampules affected by an earlier recall from the manufacturer Huons Co., Ltd.
The kits do not have to be removed. Instead, the affected ampules must not be used, and the kits should be quarantined until warning labels have been applied. The other components in the kits can still be used. The correction covers Single Shot Epidural kits (item numbers 59553 and 83945B) and Epidural/Pain TQC kits (item number 82465) from specific lots.
Key points
- FDA Class I correction; the kits are relabelled, not removed.
- Affected item numbers: 59553, 83945B and 82465 (specific lots only).
- Do not use the ampules included in affected kits; all other kit components may be used.
- Quarantine affected kits and attach the manufacturer's warning label before use.
What it means for you
Anaesthesia and pain-management teams using imported epidural kits should check item and lot numbers, and replace the affected ampules from a separate, unaffected supply.
Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.