Reported Sep 15, 2021 · Terminated
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01,…
Copan Italia
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Copan Italia · Via Francesco Perotti 10 · Brescia, N/A · N/A
Is this the product you have?
22 of 22 products
| Model / number | Product as published |
|---|---|
501CS01 | COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers , Minitip, sterile Single Wrapped, Molded bp 80mm |
501CS01Q100 | REF: 20226, , Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs |
1127700 | REF: 501CS01.Q20, , Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20 |
502CS01 | Regular, Sterile single Wrapped, Molded bp 80mm |
503CS01 | Flexible, Sterile Single Wrapped, Molded bp 100mm |
503CS01.BD | REF: 220252, , Flexible, Sterile Single Wrapped Molded bp 100 mm |
50U004DS | REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm , hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm |
50U009DS02 | hDNA Free, Regular, Sterile, 2pcs Packed |
518CS01 | Minitip, Ster. Single Wrapped, Molded bp 100mm |
518CS01.BD | REF: 220251, , Minitip, sterile Single Wrapped Molded bp 100mm |
519C/519C.BX | Regular Sterile, Molded break point 100 mm |
519CS01.BD | REF: 220250 , Regular, Sterile Single wrapped Molded bp 100mm |
525CS01 | Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm |
534CS01 | REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube , Flexible Nylon, Sterile Single Wrapped |
551C | Minitip Sterile in dry tube, Molded Break Point 80 mm |
552C/552C.BX | Regular sterile in dry tube Molded Break Point 80 mm |
553C | Flexible sterile in dry tube, molded bp 100 mm |
553C.LC | Flexible Sterile in dry tube, molded bp 100 mm |
5U002S | Regular, sterile, in tube, 80 mm breakpoint, with low stopper |
5U055S02.HG | 5U048N01.BIO, , Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch |
- Lot codes and dates
- Mode NumberLot
- number
501CS01: 1816581 and 2027890501CS01
- Q100
PJ10453PJ10636 and PJ10667501CS01
- Q20
J10407502CS01: 181696420272392027877503CS01: 18075891809095181476118147621814763181696818213622025887503CS01
- BD
2031801503CS01
- BX
50U004DS and 181868550U009DS02: 1825274518CS01: 2008058 and 2027915518CS01
- BD
2008058519C: 1816921519C
- BX
1811060 and 1816921519CS01
- BD
2027871525CS01: 2009380528C: 1808601534CS011707256551C: 1813221552C: 1819144552C
- BX
1819144553C: 1810293181644018176382004854: 553C
- LC
181197618140541814717181763718209995U002S: 18127055U048N01
- BIO
1810727 and 18189125U055S02
- HG
18144135U056S
- IUO
18164485U057S
- IUO1816451
- Amount recalled
- 3,029,400 units
Where it was sold
- Nationwide
- PR
Why it was recalled
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
This product could cause temporary or reversible health problems — stop using it.
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