CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Medline Shoulder CDS convenience kits recalled by Medline Industries
Medline Industries is recalling Medline Shoulder CDS convenience kits, distributed nationwide in the US. The recall was initiated on 1 Jul 2021 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-2231-2021
- FDA event ID
- 88268
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2021
- FDA classified
- 9 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2021 | Recall initiated by company | |
| 9 Aug 2021 | Classified by FDA | +39 days |
| 18 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kits may contain an expired component.
Product as listed by the FDA
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Where it was distributed
US Nationwide distribution in the states of MN, NE, and PA.
Questions about this recall
Is Medline Shoulder CDS convenience kits recalled?
Yes. Medline Industries recalled Medline Shoulder CDS convenience kits on 1 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2231-2021.
Why was it recalled?
The kits may contain an expired component.
Which lots are affected?
REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.
Where was it sold?
US Nationwide distribution in the states of MN, NE, and PA.
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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