CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Centurion Sterile #16 Rubber Band, Product recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion Sterile #16 Rubber Band, Product, distributed nationwide in the US. The recall was initiated on 23 Feb 2024 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-1446-2024
- FDA event ID
- 94136
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Feb 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 23 Feb 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +35 days |
| 10 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Questions about this recall
Is Centurion Sterile #16 Rubber Band, Product recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Centurion Sterile #16 Rubber Band, Product on 23 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1446-2024.
Why was it recalled?
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Which lots are affected?
UDI/DI 10653160129240 (case) 00653160129243 (each), Lot Numbers: 2023022290, 2023041190
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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