ConvaTec, Inc — Class II: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
ConvaTec, Inc has initiated a Class II recall for its Aquacel Ag Surgical SP (REF: 413556, 9cm x 15cm) sterile dressings. The recall was prompted by the product being manufactured out of specification, specifically regarding greater thickness than allowed.
Quality and manufacturing departments at ConvaTec, Inc and healthcare providers or distributors utilizing the specific 9cm x 15cm Aquacel Ag Surgical SP product.
This enforcement action highlights the critical importance of adhering to physical attribute specifications. While thickness may appear to be a minor deviation, for surgical dressings, it could impact technical performance, adhesion, or silver delivery mechanisms. This suggests a potential lapse in manufacturing controls or in-process dimensional testing at the Greensboro facility.
QA teams should review physical specification tolerances for hydrocolloid or silver-impregnated dressings and ensure current inspection methods are sensitive enough to detect out-of-specification thickness during final release testing. Regulatory teams should monitor the status of this ongoing recall to determine if a Field Safety Notice is required for existing inventory.
Class II. Reason: Surgical dressing manufactured out of specification (greater thickness).. Product: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R. Firm: ConvaTec, Inc (Greensboro NC United States). Status: Ongoing.
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