Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Reported: May 31, 2023 Initiated: April 24, 2023 #Z-1621-2023
Product Description
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Reason for Recall
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Details
- Recalling Firm
- Windstone Medical Packaging, Inc.
- Units Affected
- 60 kits
- Distribution
- US: MA OUS: None
- Location
- Billings, MT
Frequently Asked Questions
What product was recalled? ▼
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO. Recalled by Windstone Medical Packaging, Inc.. Units affected: 60 kits.
Why was this product recalled? ▼
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1621-2023.
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