CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise
CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential compromise of sterility in a medical device used for surgical procedures, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures, sterile, 12 sutures per box. The recall involves 1,905 boxes, totaling 22,860 sutures. The affected product codes are 822PG-HUF (170927-52, 180611-59), 822PG-DAR (171205-52), 810PG-1 (180924-51), and 822PG-1 (180924-53).
The recall was initiated because routine monitoring for Endotoxins resulted in an out-of-limit test result, indicating a potential compromise of the product's sterility. These sutures are indicated for general soft tissue approximation and ligation, including ophthalmic procedures, but are not intended for cardiovascular or neural tissues.
The affected products were distributed worldwide, including nationwide in the United States to Iowa, Illinois, New York, and South Carolina, as well as internationally to Canada. Healthcare facilities and consumers should stop using the affected sutures and contact CP Medical Inc for further instructions or a refund.
The recalled product
- Product
- Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural…
- Manufacturer
- CP Medical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Code (lot code): 822PG-HUF (170927-52
- 180611-59)
- 822PG-DAR (171205-52)
- 810PG-1 (180924-51)
- 822PG-1 (180924-53)
Distribution
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