INTEGRATED MEDCRAFT LLC — Class II: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. C
Integrated Medcraft LLC has initiated a Class II recall for its FORWARD Oral Airway Kit (REF 1011-40002) due to reports that Guedel Airway tips within the kit may be partially or fully occluded. The recall affects multiple OPA sizes and specific blue and light green component product codes.
This affects Integrated Medcraft LLC, healthcare facilities utilizing these specific oral airway kits, and medical device distributors and clinicians involved in respiratory care and anesthesia.
The potential for occluded or partially occluded airway tips presents a direct risk to patient ventilation and airway patency during emergency or surgical procedures. From a regulatory perspective, this suggests a failure in manufacturing quality control or inspection processes for molded components, likely requiring a formal CAPA to address the root cause of the occlusion.
QA and clinical teams should immediately identify and quarantine affected REF 1011-40002 kits. Supply chain personnel should verify specific product codes for Guedel airway components (1100050 and 1000035) and monitor for updates on the ongoing status of this recall.
Class II. Reason: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.. Product: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.. Firm: INTEGRATED MEDCRAFT LLC (East Hampton CT United States). Status: Ongoing.
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