Food, drugs, devices › CP Medical Inc
Device recall: Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430
FDA enforcement event 84178 is a device recall by CP Medical Inc of Norcross, GA, initiated 18 Oct 2019 and classified Class II, with 1 product record.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. CP Medical Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CP Medical Inc, Norcross, GA.
Reason for recall
"Failed to meet USP minimum average value for knot pull (tensile) strength."
Distribution
"USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0655-2020 | Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 | 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures | Class II | Ongoing | 18 Dec 2019 |
Context
Other enforcement events for CP Medical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Feb 2019 | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are ind | Device | Class II | 1 |
| 2 Feb 2017 | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes | Device | Class II | 1 |
All 3 events for CP Medical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Failed to meet USP minimum average value for knot pull (tensile) strength."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.