The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2676-2014·Announced 2014-10-01

Peters Surgical Recalls CARDIOFLON Evolution Sutures for Surface Splitting

Peters Surgical is recalling 22,190 units of CARDIOFLON Evolution sutures due to a potential splitting of the surface treatment on thread ends.

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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).

Plain-English summary

Peters Surgical is recalling 22,190 units of CARDIOFLON Evolution synthetic non-absorbable surgical sutures. The recall was initiated because a potential splitting of the surface treatment on the thread ends was recently identified. These sutures are composed of polyester braids, coated, with or without PLEDGETS, and are available in green or white colors.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall covers specific item references and batch numbers with expiration dates ranging from 01/2019 to 10/2019. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers should stop using the affected sutures and contact Peters Surgical for further instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some…
Manufacturer
Peters Surgical
Category
Medical Device — Surgical Sutures
Hazard
Affected units
22,190

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 (20)

  • 1) Item reference: 19P20Q
  • Batch number: 1135
  • Expiration date: 10/2018
  • GTIN on box label: 3661522034989
  • 2) Item reference: 19P30AC
  • Batch number: 942720
  • Expiration date: 03/2018
  • GTIN on box label: 3661522034446
  • 3) Item reference: 19P30AE
  • Batch number: 7627
  • Expiration date: 04/2019
  • GTIN on box label: 3661522034477
  • 4) Item reference: 19P30AE
  • Batch number: 942910
  • Expiration date: 02/2018
  • 5) Item reference: 19P30AE
  • Batch number: 971670
  • Expiration date: 05/2018
  • 6) Item reference: 19P30AK
  • Batch number: 942530

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Peters Surgical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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