COPAN FLOQSwabs Recalled Over Sterilization Integrity Failure
Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.
What this means for you
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: This is an FDA Class II recall involving sterile medical devices where sterility cannot be guaranteed due to documented integrity issues. While no injuries or illnesses have been reported, the affected devices present a risk of harm as medical devices intended for clinical sampling.
Plain-English summary
COPAN FLOQSwabs are sterile medical devices used for clinical sample collection. Copan Italia is recalling 3,029,400 units that were distributed nationwide in the US and Puerto Rico.
The recall was initiated because a sterility assurance level of 10-6 cannot be guaranteed. This is due to intentional fraud and data integrity issues at Steril Milano, the contract sterilizer. These issues mean the manufacturer cannot verify that the affected devices meet the required sterility standards.
The recalled product
- Product
- COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20,
- Manufacturer
- Copan Italia
- Affected units
- 3,029,400
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)
- Mode Number: Lot number: 501CS01: 1816581 and 2027890
- 501CS01.Q100: PJ10453
- PJ10636 and PJ10667
- 501CS01.Q20: J10407
- 502CS01: 1816964
- 2027239
- 2027877
- 503CS01: 1807589
- 1809095
- 1814761
- 1814762
- 1814763
- 1816968
- 1821362
- 2025887
- 503CS01.BD: 2031801
- 503CS01.BX: 50U004DS and 1818685
- 50U009DS02: 1825274
- 518CS01: 2008058 and 2027915
- 518CS01.BD: 2008058
Distribution
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