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Class 2 Device Recall Allen |
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Date Initiated by Firm |
September 20, 2022 |
Date Posted |
November 03, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0176-2023 |
Recall Event ID |
90848 |
Product Classification |
Table, operating-room, electrical - Product Code GDC
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Product |
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, |
Code Information |
UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
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FDA Determined Cause 2 |
Other |
Action |
The firm issued an Urgent Medical Device Correction notice to their consignee on 09/20/2022 by email. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer:
1. Identify the impacted lot number listed on page 1 and stop any use of the product immediately.
2. Hillrom will contact you to perform a correction of your impacted device as soon as possible."
The firm issued an Urgent Medical Device Recall notice to their consignees on 09/27/2022 by FedEx 2nd day delivery. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer:
1. Identify the impacted lot numbers listed in the above table and replace with the enclosed device that accompanies this notification.
2. Please return the impacted unit per RMA instructions attached within 10 business days.
Actions to be taken by Distributor:
1. Please forward this notification to your end users along with replacement parts accompanying this notification.
2. Please request return of the impacted devices from your end users and return the devices to Hillrom, per RMA instructions attached."
Both notices provided the following contact information: "Contact reference person
If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com" |
Quantity in Commerce |
2 units |
Distribution |
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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