(b)(6) hospital returned this frontal style leaded protective apron (model f17, manufactured march 10, 2017, serial number (b)(4)) to burlington medical on 9/27/2018 because the protection material on the inside of the apron was coming loose.It was initially determined the end user caused the damage to the apron, as this sort of damage is commonly caused by hanging the apron improperly.These aprons have a 2-yr manufacturer's warranty.The apron was repaired and returned to the customer.Later, after other similar devices were returned, it was determined that this apron was manufactured with ve25 from lot # 4719.It was noted that this lot of lead didn't feel the same as previous material; however, the material met all inspection requirements, so it was used in the manufacture of devices designed to protect against radiation exposure.The other returned devices are referenced in the following mdrs: 1222742-2019-00002, 1222742-2019-00003, 1222742-2019-00004, 1222742-2019-00005, 1222742-2019-00006, 1222742-2019-00007, and 1222742-2019-00008.These aprons are inspected at least annually by the user-facility, and much more often by the technicians who use them.Despite this, burlington medical has decided to take a very conservative stance and recall all protective devices made with material that was noted to have slightly different properties (didn't feel the same as previous material).The total number of products to be recalled is 4,201 and the majority are thyroid shields.A 5-day mdr has been filed to capture this remedial action (mdr 1222742-2019-00009).
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