Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patie

FDA device recall Z-0178-2023 · posted 2022-11-03 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

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.

Action taken

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"

Root cause

Other

Status

Open, Classified

Product code

GDC

Quantity affected

13 units

Distribution

MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Date initiated

2022-09-20

Date posted

2022-11-03

Location

Deerfield, IL