CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/.3 x 2.8 m) recalled
Covidien is recalling Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/.3 x 2.8 m), distributed nationwide in the US. The recall was initiated on 1 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0016-2019
- FDA event ID
- 80924
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2018
- FDA classified
- 2 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Aug 2018 | Recall initiated by company | |
| 2 Oct 2018 | Classified by FDA | +62 days |
| 10 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for product sterility breach due to a compromised or pinched seal defect
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Potential for product sterility breach due to a compromised or pinched seal defect
Which lots are affected?
Lot Numbers: 18E071762,18E072262,18E072362,18E132262,18E132362
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 80924| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dermacea Gauze Fluff Roll, 6 Ply, -1/8 yd x 3.7 m) recalled by Covidien | Covidien | Sterility | Nationwide | |
| CLASS II | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/-1/8 yd x 3.7m) recalled | Covidien | Sterility | Nationwide | |
| CLASS II | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/-1/8 yd x 3.7 m) recalled | Covidien | Sterility | Nationwide | |
| CLASS II | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/.3 x 3.7m) recalled | Covidien | Sterility | Nationwide | |
| CLASS II | Kerlix Gauze Roll, 6 Ply, Large 4-1/-1/8 yd x 3.7m) Stretched recalled | Covidien | Sterility | Nationwide |
More recalls from Covidien
All 493| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EndoFLIP System that includes recalled by Covidien | Covidien | Other | Nationwide |
| Device | CLASS II | Dermalon 88861757-31 Dermalon* 4-0 Blu C13 recalled by Covidien | Covidien | Sterility | Nationwide |
| Device | CLASS II | Surgipro SP-623 Surgipro* 2-0 BLU SC2 X36 SP recalled by Covidien | Covidien | Sterility | Nationwide |
| Device | CLASS II | V-Loc 90 Absorbable Wound Closure Device Vloc 90 0 VL recalled | Covidien | Sterility | Nationwide |
| Device | CLASS II | Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX recalled | Covidien | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |